- Email: [email protected]
The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: A clinical trial study
Accepted Manuscript The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study Abbas Ebadi, BSN, MSN, Nursing PhD Assistant Professor, Parastoo Kavei, MSc of Critical Care Nursing, Tayyeb Moradian, PhD Student in Nursing, Saeid Yaser, MSc of Critical Care Nursing PII:
S1744-3881(15)00054-7
DOI:
10.1016/j.ctcp.2015.07.001
Reference:
CTCP 595
To appear in:
Complementary Therapies in Clinical Practice
Received Date: 5 March 2015 Revised Date:
14 June 2015
Accepted Date: 3 July 2015
Please cite this article as: Ebadi A, Kavei P, Moradian T, Yaser S, The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial StudyThe effect of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study, Complementary Therapies in Clinical Practice (2015), doi: 10.1016/j.ctcp.2015.07.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT The effect of foot reflexology on physiologic parameters and mechanical
ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study Ebadi, Abbas: BSN, MSN, Nursing PhD Assistant Professor, Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah
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University of Medical Sciences. Tehran, Iran, E-Mail:[email protected] Kavei, Parastoo, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah University of Medical Sciences. Tehran, Iran, Email: [email protected]
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Moradian, Tayyeb: PhD Student in Nursing. Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah University of Medical Sciences. Tehran, Iran, Email: [email protected]
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Yaser Saeid*, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC) and Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran. Tel: +989131978416 Email: [email protected] Address for Correspondence authors:
Yaser Saeid*, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC) and
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Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran. Tel: +989131978416 Email: [email protected]
Conflicts of interests We declare that we have no conflicts of interest.
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Acknowledgment
This study was a part of a research project supported by, Baqiyatallah University of Medical
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Sciences, Tehran Iran. This clinical trial was registered in IRCT and allocated unique code (IRCT201401046778N3). The researchers would like to thank the participants for their participation in this study and we would like to thank Mr. Yaser Saeid (BSN, MSN) who provided reflexology intervention to male patients in the experimental group..
Author contributions The first author conceived and designed, collected the clinical data, interpreted the clinical data, drafted the manuscript and revised it critically for important intellectual content. The second author interpreted the clinical data; re analyzed and revised the method and results section. The authors interpreted the clinical data, revised it critically for important intellectual content and edited all the manuscript grammatically and scientific writing. The five authors
ACCEPTED MANUSCRIPT (corresponding author) conceived and designed, interpreted the clinical data, drafted the
manuscript and revised it critically for important intellectual content. All authors read and
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approved the final manuscript.
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The effect of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study
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ABSTRACT The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value < 0.05). The study findings demonstrated the efficiency of foot reflexology in shortening the length of weaning time. Keywords: Foot reflexology, Physiological parameters, Mechanical ventilation weaning, and Open-heart surgery
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INTRODUCTION The prevalence of cardiovascular diseases (CVD) has increased during recent centuries(1). Currently, CVD is the first leading cause of death, bringing sixteen million deaths yearly(2). There are numerous treatment options for CVD. One of the most common options— particularly for treating ischemic problems and valvular disorders—is open-heart surgery (OHS)(3). However, patients usually experience many physical and psychological problems in achieving recovery from OHS(4). After OHS, patients are usually transferred to OHS intensive care unit (OHS-ICU) to allow weaning from mechanical ventilation (MV) and also for receiving advanced nursing and medical care(5).
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Studies have shown that prolonged mechanical ventilation increases healthcare costs and also negatively affects patients’ cardiovascular, respiratory, digestive, and musculoskeletal systems, fluid and electrolyte balance, and psychological state(6, 7). MV-associated physical and psychological problems cause considerable stress to patients(8-10) This stress, in turn, stimulates sympathetic and neuroendocrine responses, disturbs patients’ sleep, increases cardiac muscle oxygen demand, and causes tachypnea, tachycardia, and hypertension(11). Accordingly, patients who receive MV usually are treated with sedatives, hypnotic, and tranquilizers to alleviate their pain, stress, and anxiety and also to prevent from patientventilatory asynchrony (12). However, these agents can slow the process of weaning from MV(13). An alternative method for managing patients’ pain, stress, and anxiety is nonpharmacologic interventions. Non-pharmacologic management of anxiety has received great importance during recent years. Compared with pharmacologic agents, non-pharmacologic interventions are simpler, less expensive, and non-invasive and produce fewer side effects(14). These interventions include a wide range of techniques including music therapy, praying, aromatherapy, guided imagery, muscle relaxation, meditation, reflexology, cognitive therapy, and physical exercise(15). The therapeutic application of reflexology is to produce "stimulations" on the referred reflexology areas. These can be done through alternate pressing and releasing the areas in extremities of the body, specially feet, hands and ears (16). Evidence shows that reflexology massage—as a simple, cost-effective, and non-invasive method—regulates the activity of the autonomic nervous system, coordinates physiological responses, alleviates anxiety, and induces relaxation(17, 18). Accordingly, it can be used for alleviating anxiety, preventing anxiety-related complications, and stabilizing hemodynamic condition of patients who receive MV. The effects of foot reflexology on pain, anxiety, tension, physiological parameters, fatigue, and sleep quality have been examined in different studies (19-24). However, to the best of 2
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our knowledge, few studies have been conducted so far on the efficiency of foot reflexology in reducing the length of MV weaning time in patients undergoing OHS. Accordingly, this study was conducted to reduce this gap. The aim of the study was to investigate the efficacy of foot reflexology on physiological parameters and the length of MV weaning time in patients undergoing OHS. METHODS
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Design This was a double blind three-group randomized controlled trial.
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Setting This study was conducted between February and April 2014 in two OHS-ICUs of two teaching hospitals affiliated to Baqiyatallah University of Medical Sciences, Tehran, Iran.
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Participants The target population of the study consisted of all patients who were hospitalized in cardiac surgery units of the study setting and were subjected to OHS. The inclusion criteria were having an age of 18–75 years, having a non-emergency OHS, having no foot problem (such as callus, corn, fungal skin infection, previous scars, or known neuropathy), having no intraaortic balloon pump or pace-maker in place, having a heart rate of greater than 60 beat per minute and a systolic blood pressure of higher than 90 mmHg, receiving no sedative or tranquilizer before the study intervention, and having a partial thromboplastin time of more than 60. Patients who were subjected to a second OHS, received more than one inotropic medication after surgery, needed prolonged MV based on physician’s order, or had hemodynamic instability and decreased level of consciousness were excluded from the study.
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Randomization and sample size The sample size was calculated by using the Altman’s nomogram(25) and the findings of a similar study conducted by Sadeghi-Shermeh et al. (2009). Accordingly, with a power of 90% and a confidence interval of 95%, the sample size was determined to be 30 patients in each group. Totally, 96 patients were recruited and randomly allocated to the study groups. Allocation was performed the day before the surgery by randomly selecting one of the three cards labeled groups A, B, or C. Accordingly, 34, 30 and 32 patients were randomly allocated to the experimental, placebo, and the control groups, respectively. Three patients from the experimental group and one patient from the control group were excluded from the study because of either being in need of prolonged MV based on physician’s order or having decreased consciousness. Finally, the number of patients in the experimental, placebo, and the control groups was 31, 30, and 31, respectively (Figure 1). 3
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The intervention Patients in the experimental group received foot reflexology one hour after admission to OHS-ICU. The reflexology protocol was developed by a complementary therapist and a reflexology specialist based on the foot reflexology textbooks(26, 27). All patients received the reflexology intervention in supine position in four consecutive steps. The intervention was implemented by two same-gender nurses. Both nurses had received similar reflexology trainings. Primarily, we (i.e. both male and female nurses who provided reflexology) rubbed our hands with non-therapeutic baby oil to warm, lubricate, and prepare them for the intervention. In the first step, we held the left foot in hand for one minute. In the second step, we performed the foot spread technique on the foot for one minute. This technique includes massaging and spreading the plantar surface of the foot with the thumbs of both hands from heel towards toes. In the third step, we put the four fingers of both hands on the dorsal surface of patient’s foot and used our thumbs for massaging the heart and lung area of the sole (i.e. the anterior third of the sole) in a rotating manner for 7–10 minutes. In the last step, the top sliding technique was applied for one minute. In this technique, we put the thumbs of both hands on the sole and the other four fingers on the dorsal surface of the foot and slid them with a gentle pressure from the toes towards the heel and the ankle. After massaging the left foot, we massaged the right foot in the same way. The reflexology massage of each foot lasted for ten minutes—twenty minutes in total. In the placebo group, we only touched patients’ heels for twenty minutes without exerting any pressure. Accordingly, the heart and lung area of their sole was not touched at all. Reflexology theory suggests that massaging irrelevant areas produces no therapeutic effect(28). Patients in the control group received the routine care of the study setting which included no foot massaging or touching.
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Data collection and outcome measures Patients’ demographic data were collected by using a demographic questionnaire containing questions on patients’ age, gender, body mass index, cardiac ejection fraction, the amount of time that patient had been on cardiopulmonary pump during surgery, and previous history of diabetes mellitus, hypertension, pulmonary diseases, and smoking. We collected the demographic data by both interviewing patients and referring to their medical records. Patients’ physiological parameters—including pulse rate (PR), respiratory rate (RR), systolic and diastolic blood pressures (SBP and DBP), mean arterial pressure (MAP), and percutaneous oxygen saturation (SpO2)—were monitored six times by using a Dtex electronic monitor (General Electric Co, USA). The six measurement time-points included 4
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immediately after being admitted to OHS-ICU (T1), one hour after admission (i.e. immediately before the intervention; T2), immediately after the intervention (i.e. twenty minutes after T2; T3), ten minutes after the intervention (T4), immediately after extubation (T5), and one hour after it (T6). The time interval between admission to OHS-ICU and extubation was considered as the MV weaning time and was measured by using a chronometer.
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Blinding Both the participating patients and the healthcare providers of the study setting were blind to the study intervention and allocation.
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Ethical considerations The Ethics Committee of Baqiyatallah University of Medical Sciences approved the study. We obtained written informed consent from the study participants at the day before the surgery. Patients were informed about the aim of the study and also about being free to withdraw from the study. Moreover, we ensured them that their personal information would be managed confidentially. Patients were also ascertained that their participation in or withdrawal from the study never affect their course of treatment.
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Data analysis The Statistical Package for Social Science (SPSS v. 18.0) was used for data analysis. The normality of the study variables was assessed by using the Kolmogrov-Smirnov test. Moreover, we used the one-way analysis of variance (one-way ANOVA) and the Chi-square tests for assessing the similarity of the study groups in terms of the demographic variables. The one-way ANOVA and the Tukey’s post-hoc tests were also used for examining the difference among the study groups at each measurement time-point regarding the physiological parameters. Additionally, the differences among the three study groups regarding the variations of physiological parameters across the six measurement time-points were examined by using the repeated measures ANOVA (RM-ANOVA) test. P values less than 0.05 were considered significant. FINDINGS
Demographic characteristics Study participants ranged in age from 25 to 75 years with a mean age of 58.50±10.87. Most of the study participants were male patients (51.08%). There were no statistically significant differences among the study groups in terms of the demographic characteristics (P value > 0.05; Table 1), indicating the similarity of the study groups before the intervention. 5
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Physiologic parameters The results of the one-way ANOVA test revealed that none of the differences among the three study groups in terms of physiological parameters were statistically significant (P value > 0.05; Table 2). Moreover, the results of the between-groups RM-ANOVA test also showed that the variations of the physiological parameters across the six measurement timepoints did not differ significantly among the study groups (P value > 0.05; Table 2).
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MV weaning time The means of weaning time in the experimental, placebo, and the control groups were 283.43±96.26, 365.80±148.02, and 322.54±70.95 minutes, respectively. The results of the one-way ANOVA test demonstrated that the difference among the study groups in terms of the length of weaning time was statistically significant (P value = 0.01). The results of the Tukey’s post-hoc test showed that this difference was between the experimental group and the two other groups.
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DISCUSSION This study aimed to investigate the effect of foot reflexology on physiologic parameters and the length of MV weaning time in patients undergoing OHS. Study findings revealed that foot reflexology had no significant effect on physiological parameters. Sadeghi-Shermeh et al. (2009), Khoshtarash et al. (2012), and Jones et al. (2013) also reported that foot reflexology has no significant effect on physiological and hemodynamic parameters in pregnant women undergoing caesarean section, patients undergoing cardiac surgery, and patients with chronic heart failure, respectively(20, 29, 30). However, Somchok (2006), McVicar et al. (2007), and Kuar et al. (2012) found that foot reflexology positively affects patients and healthy people’s physiological parameters(24, 31, 32). Moreover, Korhan et al. (2014) also reported that performing reflexology on foot, hand, and ear reduces heart rate, systolic and diastolic blood pressures, and respiratory rate in patients receiving MV(33). The contradiction between our findings and the findings of these studies can be attributed to differences in the technique, site, and depth of reflexology, number of reflexology sessions, patients’ underlying conditions, and modes of MV. Generally, different massaging techniques have different effects on the autonomic nervous system. For instance, gentle touch stimulates the parasympathetic response while light pressure triggers the sympathetic response. Papathanassoglou and Mpouzika (2012) also noted that the effects of massage therapies are unpredictable(34). Study findings also showed that although foot reflexology had no significant effect on physiological parameters, it significantly reduced the length of MV weaning time. The mean 6
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of weaning time in the reflexology group was 39.11 minutes shorter than the control group. Yang (2008) also found that foot reflexology significantly improves weaning parameters in patients who received prolonged MV. The exact mechanism of action of reflexology in reducing the length of weaning time is not completely understood and there is much controversy about it. Probably, reflexology exerts its effects on weaning parameters thalleviating pain and anxiety. Previous studies showed that massage therapy and foot reflexology significantly reduce pain(19, 20, 29) and anxiety(19, 33) in different patient populations. Moreover, massaging the reflexology areas of lung on foot significantly improves respiratory function which in turn can reduce MV dependence and facilitate weaningrough(28).
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CONCLUSION Study findings indicate that foot reflexology is an effective nursing intervention for facilitating MV weaning after OHS. Given the simplicity, safety, and cost-effectiveness of foot reflexology, we recommend the development and implementation of reflexology training programs for both nursing students and practicing nurses.
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Limitations The study sample was recruited from only two teaching hospitals located in Tehran, Iran. Accordingly, study findings may have limited generalizability. The other limitation of the study was that despite having the same weaning guideline, nurses who worked in the study setting had different approaches to weaning. Accordingly, controlling this variable in future studies is recommended. In addition, conducting further large-scale studies by using different designs for providing definitive evidence concerning the effects of foot reflexology on weaning time and improving evidence-based weaning practice is recommended.
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Conflict of interest
None of the authors have any conflicts of interests with regards to this research. References
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Age(years) Mean (SD)
All subjects
reflexology group (n = 31)
Placebo group (n = 30)
58.50(10.87)
60.13(11.62)
56.67(10.25)
Body Mass Index Mean (SD)
27.07 (4.37)
26.33 (3.90)
27.67 (5.72)
Ejection Friction(%) Mean (SD)
48.04 (6.84)
48.29 (5.53)
48.10 (7.88)
Hypertention, n (%) Yes No
45(48.92) 47(51.08) 62 (67.4) 30 (32.60)
63.66 (32.87) 16(51.61) 15(48.39)
62.60 (29.13)
22 (70.97) 9 (29.03)
16(53.34) 14(46.66)
19 (63.34) 11 (36.66)
ANOVA P=0.47
47.74 (7.16)
ANOVA P=0.95
65.47 (24.33)
ANOVA P= 0.92
13(41.94) 18(56.06)
21 (67.75) 10 (32.25)
15 (16.31) 77 (83.69)
6 (19.36) 25 (80.64)
5 (16.67) 25 (83.33)
4 (12.91) 27 (87.09)
Smok, n (%) Yes No
21(22.83) 71 (77.17)
7 (22.59) 24 (75.0)
7 (23.34) 23 (74.19)
7 (22.59) 24 (77.41)
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Lung disease,n (%) Yes No
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ANOVA P= .46
27.24 (3.18)
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Gender, n (%) Female Male
63.91 (28.60)
P-value
58.65(10.77)
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Pump time(minute) Mean (SD)
Control group (n = 31)
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Characteristic
Chi-Square P=0.62 X2=0.92 Chi-Square P=0.81 X2=0.40 Chi-Square P=0.78 X2=0.47 Chi-Square P=.99 X2=0.00
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Table 2: Comparison of the foot reflexology (G1), placebo (G2) and control (G3) groups on Physiologic parameters. T1 Mean (SD)
T2 Mean (SD)
T3 Mean (SD)
T4 Mean (SD)
T5 Mean (SD)
T6 Mean (SD)
Measurement Stage→ Variable↓ Group↓ G1
85.84(14.47)
89.03(16.26)
91. 19(15.97)
91.45(16.37)
98.97(14.87)
97.65(14.17)
G2
82.33(10.8)
83.93(12.5)
87.90(13.05)
87.03(13.51)
91.30(14.27
91.93(14.03)
G3
89.06(18.64)
90.61(19.02)
91.81(17.84)
92.81(17.36)
97.03(18.30)
94.97(16.6)
G1
12.42(0.9)
12.42(1.31)
12.77(1.40)
13.03(2.07)
15.94(2.67)
18.26(3.94)
G2
11.90(0.96)
11.97(1.24)
12. 77(2.83)
12.90(2.12)
16.87(3.21)
17.37(3.47)
G3
11.74(1.06)
11.68(2.12)
12.26(1.71)
12.48(1.69)
17.39(3.97)
17.94(4.25)
G1
110.39(17.0)
126.32(15.1)
125.13(13.1)
126.19(17.5)
127.32(16.02)
121.65(18.1)
G2
108.87(15.0)
126.17(15.15)
128.20(18.44)
125.87(17.7)
122.87(14.5)
114.93(16.0)
G3
101.77(19.6)
116.39(14.4)
115.32(12.37)
115.29(13.89)
121.81(17.57)
116.97(18.11)
G1
59.52(18.94)
68.06(15.4)
69.16(13.19)
70.19(13.7)
69.48(11.32)
67.48(8.7)
G2
55.53(8.4)
68.13(11.5)
70.33(11.5)
68.30(11.6)
66.60(10.0)
65.30(11.1)
G3
55.32(12.7)
66.35(14.9)
67.87(13.2
67.06(12.1)
70.71(13.3)
68.16(14.6)
G1
76.47(15.3)
87.48(13.4)
87.81(11.18)
88.86(12.9)
88.76(11.00
85.20(10.47)
G2
73.31(9.2)
87.47(11.2)
89.62(12.8)
87.48(12.7)
85.35(9.7)
81.84(10.7)
G3
70.8(13.2)
83.03(12.9)
83.68(11.38)
83.13(10.66)
87.3274(12.8)
84.43(13.7)
G1
98.03(2.4)
97.71(2.4)
97.81(2.2)
97.90(2.2)
96.19(2.5)
96.13(3.0)
G2
98.23(2.5)
98.73(1.2)
98.1 (2.1)
98.23(1.9)
97.40(1.4)
96.13(2.5)
G3
97.84(2.7)
98.03(1.6)
98.3(1.1)
97 (1.57)
96.90(1.8)
96.55(1.7)
MAP
SPO2
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DBP
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SBP
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RR
P=0.48 F=.95
P=0.21 F=1.32
P=0.06 F=1.75
P=0.37 F=1.08
P=0.12 F=1.54
P=0.48 F=.95
immediately after being admitted to OHS-ICU (T1), one hour after admission (T2), immediately after the intervention (T3), ten minutes after the intervention (T4), immediately after extubation (T5), and one hour after it (T6).
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PR
RMANOVA
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Assessed for eligibility, n = 142 Excluded (n =46) Did not have the inclusion criteria
Randomized Allocation (n = 96)
Allocated to placebo (n = 30)
Lost to follow-up (n =3)
Lost to follow-up (n = 0)
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needed prolonged MV based on physician’s order=2
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decreased level of consciousness=1
Analyzed (n=31) Exclude from the analysis (n=0)
Allocated to control (n = 32)
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Allocated to experimental (n = 34)
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Allocation Random
Analyzed (n=30) Exclude from the analysis (n=0)
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Figure 1: CONSORT diagram
Follow-Up
Lost to follow-up (n = 1)
needed prolonged MV based on physician’s order=1
Analysis Analyzed (n= 31) Exclude from the analysis (n=0)
S1744-3881(15)00054-7
DOI:
10.1016/j.ctcp.2015.07.001
Reference:
CTCP 595
To appear in:
Complementary Therapies in Clinical Practice
Received Date: 5 March 2015 Revised Date:
14 June 2015
Accepted Date: 3 July 2015
Please cite this article as: Ebadi A, Kavei P, Moradian T, Yaser S, The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial StudyThe effect of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study, Complementary Therapies in Clinical Practice (2015), doi: 10.1016/j.ctcp.2015.07.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT The effect of foot reflexology on physiologic parameters and mechanical
ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study Ebadi, Abbas: BSN, MSN, Nursing PhD Assistant Professor, Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah
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University of Medical Sciences. Tehran, Iran, E-Mail:[email protected] Kavei, Parastoo, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah University of Medical Sciences. Tehran, Iran, Email: [email protected]
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Moradian, Tayyeb: PhD Student in Nursing. Behavioral Sciences Research Center (BSRC), Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran Baqiyatallah University of Medical Sciences. Tehran, Iran, Email: [email protected]
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Yaser Saeid*, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC) and Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran. Tel: +989131978416 Email: [email protected] Address for Correspondence authors:
Yaser Saeid*, MSc of Critical Care Nursing, Behavioral Sciences Research Center (BSRC) and
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Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran. Tel: +989131978416 Email: [email protected]
Conflicts of interests We declare that we have no conflicts of interest.
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Acknowledgment
This study was a part of a research project supported by, Baqiyatallah University of Medical
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Sciences, Tehran Iran. This clinical trial was registered in IRCT and allocated unique code (IRCT201401046778N3). The researchers would like to thank the participants for their participation in this study and we would like to thank Mr. Yaser Saeid (BSN, MSN) who provided reflexology intervention to male patients in the experimental group..
Author contributions The first author conceived and designed, collected the clinical data, interpreted the clinical data, drafted the manuscript and revised it critically for important intellectual content. The second author interpreted the clinical data; re analyzed and revised the method and results section. The authors interpreted the clinical data, revised it critically for important intellectual content and edited all the manuscript grammatically and scientific writing. The five authors
ACCEPTED MANUSCRIPT (corresponding author) conceived and designed, interpreted the clinical data, drafted the
manuscript and revised it critically for important intellectual content. All authors read and
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approved the final manuscript.
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The effect of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: a clinical trial Study
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ABSTRACT The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value < 0.05). The study findings demonstrated the efficiency of foot reflexology in shortening the length of weaning time. Keywords: Foot reflexology, Physiological parameters, Mechanical ventilation weaning, and Open-heart surgery
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INTRODUCTION The prevalence of cardiovascular diseases (CVD) has increased during recent centuries(1). Currently, CVD is the first leading cause of death, bringing sixteen million deaths yearly(2). There are numerous treatment options for CVD. One of the most common options— particularly for treating ischemic problems and valvular disorders—is open-heart surgery (OHS)(3). However, patients usually experience many physical and psychological problems in achieving recovery from OHS(4). After OHS, patients are usually transferred to OHS intensive care unit (OHS-ICU) to allow weaning from mechanical ventilation (MV) and also for receiving advanced nursing and medical care(5).
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Studies have shown that prolonged mechanical ventilation increases healthcare costs and also negatively affects patients’ cardiovascular, respiratory, digestive, and musculoskeletal systems, fluid and electrolyte balance, and psychological state(6, 7). MV-associated physical and psychological problems cause considerable stress to patients(8-10) This stress, in turn, stimulates sympathetic and neuroendocrine responses, disturbs patients’ sleep, increases cardiac muscle oxygen demand, and causes tachypnea, tachycardia, and hypertension(11). Accordingly, patients who receive MV usually are treated with sedatives, hypnotic, and tranquilizers to alleviate their pain, stress, and anxiety and also to prevent from patientventilatory asynchrony (12). However, these agents can slow the process of weaning from MV(13). An alternative method for managing patients’ pain, stress, and anxiety is nonpharmacologic interventions. Non-pharmacologic management of anxiety has received great importance during recent years. Compared with pharmacologic agents, non-pharmacologic interventions are simpler, less expensive, and non-invasive and produce fewer side effects(14). These interventions include a wide range of techniques including music therapy, praying, aromatherapy, guided imagery, muscle relaxation, meditation, reflexology, cognitive therapy, and physical exercise(15). The therapeutic application of reflexology is to produce "stimulations" on the referred reflexology areas. These can be done through alternate pressing and releasing the areas in extremities of the body, specially feet, hands and ears (16). Evidence shows that reflexology massage—as a simple, cost-effective, and non-invasive method—regulates the activity of the autonomic nervous system, coordinates physiological responses, alleviates anxiety, and induces relaxation(17, 18). Accordingly, it can be used for alleviating anxiety, preventing anxiety-related complications, and stabilizing hemodynamic condition of patients who receive MV. The effects of foot reflexology on pain, anxiety, tension, physiological parameters, fatigue, and sleep quality have been examined in different studies (19-24). However, to the best of 2
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our knowledge, few studies have been conducted so far on the efficiency of foot reflexology in reducing the length of MV weaning time in patients undergoing OHS. Accordingly, this study was conducted to reduce this gap. The aim of the study was to investigate the efficacy of foot reflexology on physiological parameters and the length of MV weaning time in patients undergoing OHS. METHODS
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Design This was a double blind three-group randomized controlled trial.
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Setting This study was conducted between February and April 2014 in two OHS-ICUs of two teaching hospitals affiliated to Baqiyatallah University of Medical Sciences, Tehran, Iran.
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Participants The target population of the study consisted of all patients who were hospitalized in cardiac surgery units of the study setting and were subjected to OHS. The inclusion criteria were having an age of 18–75 years, having a non-emergency OHS, having no foot problem (such as callus, corn, fungal skin infection, previous scars, or known neuropathy), having no intraaortic balloon pump or pace-maker in place, having a heart rate of greater than 60 beat per minute and a systolic blood pressure of higher than 90 mmHg, receiving no sedative or tranquilizer before the study intervention, and having a partial thromboplastin time of more than 60. Patients who were subjected to a second OHS, received more than one inotropic medication after surgery, needed prolonged MV based on physician’s order, or had hemodynamic instability and decreased level of consciousness were excluded from the study.
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Randomization and sample size The sample size was calculated by using the Altman’s nomogram(25) and the findings of a similar study conducted by Sadeghi-Shermeh et al. (2009). Accordingly, with a power of 90% and a confidence interval of 95%, the sample size was determined to be 30 patients in each group. Totally, 96 patients were recruited and randomly allocated to the study groups. Allocation was performed the day before the surgery by randomly selecting one of the three cards labeled groups A, B, or C. Accordingly, 34, 30 and 32 patients were randomly allocated to the experimental, placebo, and the control groups, respectively. Three patients from the experimental group and one patient from the control group were excluded from the study because of either being in need of prolonged MV based on physician’s order or having decreased consciousness. Finally, the number of patients in the experimental, placebo, and the control groups was 31, 30, and 31, respectively (Figure 1). 3
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The intervention Patients in the experimental group received foot reflexology one hour after admission to OHS-ICU. The reflexology protocol was developed by a complementary therapist and a reflexology specialist based on the foot reflexology textbooks(26, 27). All patients received the reflexology intervention in supine position in four consecutive steps. The intervention was implemented by two same-gender nurses. Both nurses had received similar reflexology trainings. Primarily, we (i.e. both male and female nurses who provided reflexology) rubbed our hands with non-therapeutic baby oil to warm, lubricate, and prepare them for the intervention. In the first step, we held the left foot in hand for one minute. In the second step, we performed the foot spread technique on the foot for one minute. This technique includes massaging and spreading the plantar surface of the foot with the thumbs of both hands from heel towards toes. In the third step, we put the four fingers of both hands on the dorsal surface of patient’s foot and used our thumbs for massaging the heart and lung area of the sole (i.e. the anterior third of the sole) in a rotating manner for 7–10 minutes. In the last step, the top sliding technique was applied for one minute. In this technique, we put the thumbs of both hands on the sole and the other four fingers on the dorsal surface of the foot and slid them with a gentle pressure from the toes towards the heel and the ankle. After massaging the left foot, we massaged the right foot in the same way. The reflexology massage of each foot lasted for ten minutes—twenty minutes in total. In the placebo group, we only touched patients’ heels for twenty minutes without exerting any pressure. Accordingly, the heart and lung area of their sole was not touched at all. Reflexology theory suggests that massaging irrelevant areas produces no therapeutic effect(28). Patients in the control group received the routine care of the study setting which included no foot massaging or touching.
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Data collection and outcome measures Patients’ demographic data were collected by using a demographic questionnaire containing questions on patients’ age, gender, body mass index, cardiac ejection fraction, the amount of time that patient had been on cardiopulmonary pump during surgery, and previous history of diabetes mellitus, hypertension, pulmonary diseases, and smoking. We collected the demographic data by both interviewing patients and referring to their medical records. Patients’ physiological parameters—including pulse rate (PR), respiratory rate (RR), systolic and diastolic blood pressures (SBP and DBP), mean arterial pressure (MAP), and percutaneous oxygen saturation (SpO2)—were monitored six times by using a Dtex electronic monitor (General Electric Co, USA). The six measurement time-points included 4
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immediately after being admitted to OHS-ICU (T1), one hour after admission (i.e. immediately before the intervention; T2), immediately after the intervention (i.e. twenty minutes after T2; T3), ten minutes after the intervention (T4), immediately after extubation (T5), and one hour after it (T6). The time interval between admission to OHS-ICU and extubation was considered as the MV weaning time and was measured by using a chronometer.
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Blinding Both the participating patients and the healthcare providers of the study setting were blind to the study intervention and allocation.
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Ethical considerations The Ethics Committee of Baqiyatallah University of Medical Sciences approved the study. We obtained written informed consent from the study participants at the day before the surgery. Patients were informed about the aim of the study and also about being free to withdraw from the study. Moreover, we ensured them that their personal information would be managed confidentially. Patients were also ascertained that their participation in or withdrawal from the study never affect their course of treatment.
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Data analysis The Statistical Package for Social Science (SPSS v. 18.0) was used for data analysis. The normality of the study variables was assessed by using the Kolmogrov-Smirnov test. Moreover, we used the one-way analysis of variance (one-way ANOVA) and the Chi-square tests for assessing the similarity of the study groups in terms of the demographic variables. The one-way ANOVA and the Tukey’s post-hoc tests were also used for examining the difference among the study groups at each measurement time-point regarding the physiological parameters. Additionally, the differences among the three study groups regarding the variations of physiological parameters across the six measurement time-points were examined by using the repeated measures ANOVA (RM-ANOVA) test. P values less than 0.05 were considered significant. FINDINGS
Demographic characteristics Study participants ranged in age from 25 to 75 years with a mean age of 58.50±10.87. Most of the study participants were male patients (51.08%). There were no statistically significant differences among the study groups in terms of the demographic characteristics (P value > 0.05; Table 1), indicating the similarity of the study groups before the intervention. 5
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Physiologic parameters The results of the one-way ANOVA test revealed that none of the differences among the three study groups in terms of physiological parameters were statistically significant (P value > 0.05; Table 2). Moreover, the results of the between-groups RM-ANOVA test also showed that the variations of the physiological parameters across the six measurement timepoints did not differ significantly among the study groups (P value > 0.05; Table 2).
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MV weaning time The means of weaning time in the experimental, placebo, and the control groups were 283.43±96.26, 365.80±148.02, and 322.54±70.95 minutes, respectively. The results of the one-way ANOVA test demonstrated that the difference among the study groups in terms of the length of weaning time was statistically significant (P value = 0.01). The results of the Tukey’s post-hoc test showed that this difference was between the experimental group and the two other groups.
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DISCUSSION This study aimed to investigate the effect of foot reflexology on physiologic parameters and the length of MV weaning time in patients undergoing OHS. Study findings revealed that foot reflexology had no significant effect on physiological parameters. Sadeghi-Shermeh et al. (2009), Khoshtarash et al. (2012), and Jones et al. (2013) also reported that foot reflexology has no significant effect on physiological and hemodynamic parameters in pregnant women undergoing caesarean section, patients undergoing cardiac surgery, and patients with chronic heart failure, respectively(20, 29, 30). However, Somchok (2006), McVicar et al. (2007), and Kuar et al. (2012) found that foot reflexology positively affects patients and healthy people’s physiological parameters(24, 31, 32). Moreover, Korhan et al. (2014) also reported that performing reflexology on foot, hand, and ear reduces heart rate, systolic and diastolic blood pressures, and respiratory rate in patients receiving MV(33). The contradiction between our findings and the findings of these studies can be attributed to differences in the technique, site, and depth of reflexology, number of reflexology sessions, patients’ underlying conditions, and modes of MV. Generally, different massaging techniques have different effects on the autonomic nervous system. For instance, gentle touch stimulates the parasympathetic response while light pressure triggers the sympathetic response. Papathanassoglou and Mpouzika (2012) also noted that the effects of massage therapies are unpredictable(34). Study findings also showed that although foot reflexology had no significant effect on physiological parameters, it significantly reduced the length of MV weaning time. The mean 6
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of weaning time in the reflexology group was 39.11 minutes shorter than the control group. Yang (2008) also found that foot reflexology significantly improves weaning parameters in patients who received prolonged MV. The exact mechanism of action of reflexology in reducing the length of weaning time is not completely understood and there is much controversy about it. Probably, reflexology exerts its effects on weaning parameters thalleviating pain and anxiety. Previous studies showed that massage therapy and foot reflexology significantly reduce pain(19, 20, 29) and anxiety(19, 33) in different patient populations. Moreover, massaging the reflexology areas of lung on foot significantly improves respiratory function which in turn can reduce MV dependence and facilitate weaningrough(28).
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CONCLUSION Study findings indicate that foot reflexology is an effective nursing intervention for facilitating MV weaning after OHS. Given the simplicity, safety, and cost-effectiveness of foot reflexology, we recommend the development and implementation of reflexology training programs for both nursing students and practicing nurses.
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Limitations The study sample was recruited from only two teaching hospitals located in Tehran, Iran. Accordingly, study findings may have limited generalizability. The other limitation of the study was that despite having the same weaning guideline, nurses who worked in the study setting had different approaches to weaning. Accordingly, controlling this variable in future studies is recommended. In addition, conducting further large-scale studies by using different designs for providing definitive evidence concerning the effects of foot reflexology on weaning time and improving evidence-based weaning practice is recommended.
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Conflict of interest
None of the authors have any conflicts of interests with regards to this research. References
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3. Sendelbach SE, Halm MA, Doran KA, Miller EH, Gaillard P. Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. Journal of Cardiovascular Nursing. 2006;21(3):194-200. 4. Lindsay GM, Smith LN, Hanlon P, Wheatley D. Coronary artery disease patients’ perception of their health and expectations of benefit following coronary artery bypass grafting. Journal of advanced nursing. 2000;32(6):1412-21. 5. Jalalian H, Aslani J, Panahi Y. Factors Affecting the Duration of Mechanical Ventilation Device Isolation of Patients in Intensive Care Units. Kowsar Medical Journal. 2009;14(3):163-8. 6. HOSSEINI MOHAMMAD RJ. The assessment of Apache II scoring system as predictor the outcomes of weaning from mechanical ventilation. KNOWLEDGE AND HEALTH. 2007;2(3):2. 7. McLean SE, Jensen LA, Schroeder DG, Gibney NR, Skjodt NM. Improving adherence to a mechanical ventilation weaning protocol for critically ill adults: outcomes after an implementation program. American Journal of Critical Care. 2006;15(3):299-309. 8. Hamel MB, Phillips RS, Davis RB, Teno J, Connors Jr AF, Desbiens N, et al. Outcomes and cost-effectiveness of ventilator support and aggressive care for patients with acute respiratory failure due to pneumonia or acute respiratory distress syndrome. The American journal of medicine. 2000;109(8):614-20. 9. Chlan L. Integrating nonpharmacological, adjunctive interventions into critical care practice: A means to humanize care? American Journal of Critical Care. 2002;11(1):14-6. 10. Wojnicki-Johansson G. Communication between nurse and patient during ventilator treatment: patient reports and RN evaluations. Intensive and Critical Care Nursing. 2001;17(1):29-39. 11. Chlan LL. Description of anxiety levels by individual differences and clinical factors in patients receiving mechanical ventilatory support. Heart & Lung: The Journal of Acute and Critical Care. 2003;32(4):275-82. 12. Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguía C, Soto L, et al. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. CHEST Journal. 2005;128(2):496-506. 13. Lee OKA, Chung YFL, Chan MF, Chan WM. Music and its effect on the physiological responses and anxiety levels of patients receiving mechanical ventilation: a pilot study. Journal of Clinical Nursing. 2005;14(5):609-20. 14. Zakerimoghadam M, Shaban M, Mehran A, Hashemi S. Effect of Muscle Relaxation on Anxiety of Patients Undergo Cardiac Catheterization. Hayat. [Research]. 2010;16(2):64-71. 15. Morton PG, Fontaine DK, Hudak C, Gallo B. Critical care nursing: a holistic approach: Lippincott Williams & Wilkins Philadelphia; 2005. 16. Stephenson NL, Dalton JA. Using Reflexology for Pain Management A Review. Journal of Holistic Nursing. 2003;21(2):179-91. IMANI E, MOSHTAGH EZ, ALI HT, ALAVIMAJD H, ABED SZ. THE EFFECT OF FOOT MASSAGE 17. ON PHYSIOLOGICAL INDICATORS OF FEMALE PATIENTS WITH CVA ADMITTED IN THE ICU. JOURNAL OF SHAHID SADOUGHI UNIVERSITY OF MEDICAL SCIENCES AND HEALTH SERVICES. 2009;17(2):209-15. 18. Krirnakriengkrai S, Kumar S, Hughes CM, McDonough SM. An experimental study on the effect of reflexology on the nervous system in healthy adults. Complementary Therapies in Medicine. 2010;18(6):272.
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Age(years) Mean (SD)
All subjects
reflexology group (n = 31)
Placebo group (n = 30)
58.50(10.87)
60.13(11.62)
56.67(10.25)
Body Mass Index Mean (SD)
27.07 (4.37)
26.33 (3.90)
27.67 (5.72)
Ejection Friction(%) Mean (SD)
48.04 (6.84)
48.29 (5.53)
48.10 (7.88)
Hypertention, n (%) Yes No
45(48.92) 47(51.08) 62 (67.4) 30 (32.60)
63.66 (32.87) 16(51.61) 15(48.39)
62.60 (29.13)
22 (70.97) 9 (29.03)
16(53.34) 14(46.66)
19 (63.34) 11 (36.66)
ANOVA P=0.47
47.74 (7.16)
ANOVA P=0.95
65.47 (24.33)
ANOVA P= 0.92
13(41.94) 18(56.06)
21 (67.75) 10 (32.25)
15 (16.31) 77 (83.69)
6 (19.36) 25 (80.64)
5 (16.67) 25 (83.33)
4 (12.91) 27 (87.09)
Smok, n (%) Yes No
21(22.83) 71 (77.17)
7 (22.59) 24 (75.0)
7 (23.34) 23 (74.19)
7 (22.59) 24 (77.41)
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Lung disease,n (%) Yes No
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ANOVA P= .46
27.24 (3.18)
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Gender, n (%) Female Male
63.91 (28.60)
P-value
58.65(10.77)
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Pump time(minute) Mean (SD)
Control group (n = 31)
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Characteristic
Chi-Square P=0.62 X2=0.92 Chi-Square P=0.81 X2=0.40 Chi-Square P=0.78 X2=0.47 Chi-Square P=.99 X2=0.00
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Table 2: Comparison of the foot reflexology (G1), placebo (G2) and control (G3) groups on Physiologic parameters. T1 Mean (SD)
T2 Mean (SD)
T3 Mean (SD)
T4 Mean (SD)
T5 Mean (SD)
T6 Mean (SD)
Measurement Stage→ Variable↓ Group↓ G1
85.84(14.47)
89.03(16.26)
91. 19(15.97)
91.45(16.37)
98.97(14.87)
97.65(14.17)
G2
82.33(10.8)
83.93(12.5)
87.90(13.05)
87.03(13.51)
91.30(14.27
91.93(14.03)
G3
89.06(18.64)
90.61(19.02)
91.81(17.84)
92.81(17.36)
97.03(18.30)
94.97(16.6)
G1
12.42(0.9)
12.42(1.31)
12.77(1.40)
13.03(2.07)
15.94(2.67)
18.26(3.94)
G2
11.90(0.96)
11.97(1.24)
12. 77(2.83)
12.90(2.12)
16.87(3.21)
17.37(3.47)
G3
11.74(1.06)
11.68(2.12)
12.26(1.71)
12.48(1.69)
17.39(3.97)
17.94(4.25)
G1
110.39(17.0)
126.32(15.1)
125.13(13.1)
126.19(17.5)
127.32(16.02)
121.65(18.1)
G2
108.87(15.0)
126.17(15.15)
128.20(18.44)
125.87(17.7)
122.87(14.5)
114.93(16.0)
G3
101.77(19.6)
116.39(14.4)
115.32(12.37)
115.29(13.89)
121.81(17.57)
116.97(18.11)
G1
59.52(18.94)
68.06(15.4)
69.16(13.19)
70.19(13.7)
69.48(11.32)
67.48(8.7)
G2
55.53(8.4)
68.13(11.5)
70.33(11.5)
68.30(11.6)
66.60(10.0)
65.30(11.1)
G3
55.32(12.7)
66.35(14.9)
67.87(13.2
67.06(12.1)
70.71(13.3)
68.16(14.6)
G1
76.47(15.3)
87.48(13.4)
87.81(11.18)
88.86(12.9)
88.76(11.00
85.20(10.47)
G2
73.31(9.2)
87.47(11.2)
89.62(12.8)
87.48(12.7)
85.35(9.7)
81.84(10.7)
G3
70.8(13.2)
83.03(12.9)
83.68(11.38)
83.13(10.66)
87.3274(12.8)
84.43(13.7)
G1
98.03(2.4)
97.71(2.4)
97.81(2.2)
97.90(2.2)
96.19(2.5)
96.13(3.0)
G2
98.23(2.5)
98.73(1.2)
98.1 (2.1)
98.23(1.9)
97.40(1.4)
96.13(2.5)
G3
97.84(2.7)
98.03(1.6)
98.3(1.1)
97 (1.57)
96.90(1.8)
96.55(1.7)
MAP
SPO2
RI PT
SC
M AN U
DBP
TE D
SBP
EP
RR
P=0.48 F=.95
P=0.21 F=1.32
P=0.06 F=1.75
P=0.37 F=1.08
P=0.12 F=1.54
P=0.48 F=.95
immediately after being admitted to OHS-ICU (T1), one hour after admission (T2), immediately after the intervention (T3), ten minutes after the intervention (T4), immediately after extubation (T5), and one hour after it (T6).
AC C
PR
RMANOVA
ACCEPTED MANUSCRIPT
Assessed for eligibility, n = 142 Excluded (n =46) Did not have the inclusion criteria
Randomized Allocation (n = 96)
Allocated to placebo (n = 30)
Lost to follow-up (n =3)
Lost to follow-up (n = 0)
M AN U
needed prolonged MV based on physician’s order=2
TE D
decreased level of consciousness=1
Analyzed (n=31) Exclude from the analysis (n=0)
Allocated to control (n = 32)
SC
Allocated to experimental (n = 34)
RI PT
Allocation Random
Analyzed (n=30) Exclude from the analysis (n=0)
AC C
EP
Figure 1: CONSORT diagram
Follow-Up
Lost to follow-up (n = 1)
needed prolonged MV based on physician’s order=1
Analysis Analyzed (n= 31) Exclude from the analysis (n=0)