Complementary Therapies in Clinical Practice 38 (2020) 101068
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The effects of foot reflexology on back pain after coronary angiography: A randomized controlled trial Mojgan Kardan a, Bahare Zarei a, Hamidreza BahramiTaghanaki b, Seyyed Abolfazl Vagharseyyedin c, *, Nahid Azdaki d a
Department of Nursing, Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran Department of Chinese and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran Faculty of Nursing and Midwifery College, Birjand University of Medical Sciences, Birjand, Iran d Department of Cardiology, School of Medicine, Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran b c
A R T I C L E I N F O
A B S T R A C T
Keywords: Back pain Foot reflexology Coronary angiography
Background and aims: Back pain is among the most common complaints of patients during the first hours after coronary angiography (CA), i.e. when they are restricted to complete bed rest. This study aimed to evaluate the effects of foot reflexology on back pain after CA. Methods: This randomized controlled trial was conducted in 2018–2019 on patients hospitalized in the postangiography unit of Razi hospital, Birjand, Iran. Through convenience sampling, 120 patients were recruited and their demographic characteristics and baseline back pain intensity were assessed immediately after angi ography using a demographic questionnaire and a visual analogue scale, respectively. Then, patients were randomly allocated to a control (n ¼ 60) and a reflexology (n ¼ 60) group through block randomization. Patients in the reflexology group received 8-min foot reflexology for each foot (16 min for both feet) while their coun terparts in the control group solely received routine post-angiography care services. Back pain assessment was repeated for all participants immediately, two, four, and 6 h after the intervention. Data were analyzed using the SPSS software (v. 16.0). Findings: Back pain intensity significantly increased after angiography in both groups (P < 0.05). Yet, pain in tensity in the reflexology group at all post-intervention measurement time points was significantly less than the control group (P < 0.001). Conclusion: Foot reflexology is effective in significantly reducing back pain after CA.
1. Introduction Coronary angiography (CA) is the gold standard for the diagnosis of coronary artery disease [1]. In most of the CA procedures, a catheter is inserted into the femoral artery through a puncture in the groin site and guided towards the heart. Then, a dye is injected through this catheter into coronary arteries in order to assess the extent and the severity of coronary artery stenosis [2–4]. In 1.5%–4% of cases, traumatization of the femoral artery during CA can cause complications such as bleeding, hematoma, arterial thrombosis, and emboli [5,6]. Traditionally, post-CA complete bed rest for about 6 h is prescribed to minimize the risk of these complications [7]. During this 6-h complete bed rest, the patient should lie in flat position with straight feet and avoid rapid movements [8].
Post-CA complete bed rest may be an unpleasant experience for pa tients so that they describe immobility as the most important cause of discomfort after CA. Such immobility can result in pain [8]. Anecdotal evidence shows back pain as the most common complaint after CA [8–10]. Post-CA back pain can increase sympathetic stimulation and thereby, increase heart rate, blood pressure, cardiac workload, and myocardial oxygen consumption. These problems can in turn cause or aggravate myocardial ischemia [11–13]. Therefore, the management of post-CA back pain, particularly among patients with serious cardiac problems, is of great importance. There are different pharmacological and non-pharmacological methods for pain reduction. Pain medications are the most common pain reduction method. However, these medications are associated with
* Corresponding Author. Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari Avenue, Birjand, Southern Khorasan, 97175-379, Iran. E-mail addresses:
[email protected] (M. Kardan),
[email protected] (B. Zarei),
[email protected] (H. BahramiTaghanaki), Waghars@bums. ac.ir (S.A. Vagharseyyedin),
[email protected] (N. Azdaki). https://doi.org/10.1016/j.ctcp.2019.101068 Received 7 August 2019; Received in revised form 23 October 2019; Accepted 24 October 2019 Available online 8 November 2019 1744-3881/© 2019 Published by Elsevier Ltd.
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different side effects such as inadequate pain reduction, respiratory depression, somnolence, nausea, vomiting, and paralytic ileus [14–17]. Therefore, healthcare providers resorted to safer complementary and alternative medicine therapies which can potentially reduce pain without causing serious side effects [18–20]. Massage is one the com plementary therapies with potential pain-reducing effects. It reduces pain through reducing cortisol and norepinephrine levels, increasing serotonin level, stimulating endorphin release, facilitating blood flow, and improving oxygenation in soft tissues [21–25]. Another mechanism of action for massage is described by the gate control theory which holds that massage stimulates large nerve fibers and thereby, blocks the transmission of pain signals to the central nervous system [26]. Reflexology is among the common massage therapy methods. During reflexology, pressure is applied on certain points of the palm, sole, and earlobe [27]. Reflexologists believe that pressure application on certain points of the palm and the sole promotes blood flow in different points of the body [28] and thereby, improves balance and promotes comfort throughout the body [29,30]. Moreover, reflexology can promote comfort through positively affecting psychological responses [31]. Foot reflexology is among the most common types of reflexology. In foot reflexology, application of a certain amount of pressure on certain points of the sole can affect parts of the body which are related to those points [28]. Foot reflexology facilitates blood and lymph circulation in the body and thereby, expedites waste product removal from the body, softens and stabilizes the movements of the muscles, joints, and tendons, boosts muscular strength, and induces relaxation [32]. Foot reflexology is a simple inexpensive non-invasive procedure which can be used everywhere without any need for specific equipment and without dis turbing patient privacy [33]. Previous studies reported the positive ef fects of foot reflexology on the quality of sleep, blood pressure, and anxiety in patients with coronary diseases [34–36]. Also, the positive effects of this intervention have been shown on pain intensity in patients with low back pain [30,37]. However, to the best of our knowledge, no study had yet evaluated its effects on post-CA back pain. The present study was conducted to narrow this gap. The aim of the study was to evaluate the effects of foot reflexology on back pain after CA.
participants were randomly allocated to a control and a reflexology group through block randomization with a block size of 4 and a randomization ratio of 1:1 (Fig. 1).
2. Methods
The study intervention was foot reflexology which was provided by the first author to the participants in the intervention group immediately after their admission to the post-CA unit. The first author was trained for foot reflexology under the supervision of a Traditional Chinese Medicine specialist and received a credible certification of training from the College of Iranian and Complementary Medicine in Mashhad city, Iran. Initially, the therapist washed her hands and the intended patient’s feet using soap and fresh water, placed the patient in the supine position, stood at the bottom of his/her bed, and relaxed right foot muscles using gentle massage techniques such as traction and rotation which lasted 2 min. Then, she held and supported the foot with her left hand and exerted gentle pressure using the thumbs on the solar plexus and the spinal column reflex areas (Box 1) at a pressure of 3–4 kg. General foot massage, solar plexus reflexology, and spinal column reflexology each lasted 2 min with a 1-min interval between every two massage techni ques—eight minutes in total. The same procedure was used for the left foot with the same massage duration. The time interval between the right and the left foot reflexology was 2 min. Thus, the whole reflexology intervention for both feet lasted 18 min. Participants in the control group received routine post-CA care services which included no foot reflexology.
2.2. Instruments and data collection Data were collected using a demographic questionnaire and a visual analogue scale (VAS). The items of the demographic questionnaire were on age, gender, marital status, educational level, CA duration, body mass index, history of back pain, and smoking history. VAS was used for pain intensity assessment. VAS is among the most commonly used in struments for pain assessment. It is a continuous 100-mm line, the two ends of which represent “No pain” and “Most severe pain” (Fig. 2). Thus, the total pain intensity score measured using VAS can be 0–100. We asked each study participant to rate his/her current back pain intensity using VAS and then, measured the distance between the “No pain” point and the point marked by the participant and considered it as his/her back pain intensity score. VAS has acceptable sensitivity to determine the effects of treatments [39–41] and has frequently been used for pain assessment among patients with acute and sub-acute back pain [42–44]. Previous studies have indicated that the VAS is a methodologically sound scale for assessing acute pain, including abdominal and back pain [45,46]. The reliability of this scale is established with patients suffering from acute low back pain [46]. In the present study, interclass correla tion coefficients (ICC) were calculated to examine the test-retest reli ability between two consecutive periods for the VAS for 15 post-CA patients with mild to moderate back pain. The interval of the two measurements was 5 min. The results of test-retest indicate that the VAS was of good reliability with the ICC value of 0.83. Pain assessment for patients in both groups in the present study was performed at five time points, namely immediately after admission to the post-CA unit (T0), 20 min afterwards, i.e. immediately after the intervention (T1), 2 h after the intervention (T2), 4 h after the inter vention (T3), and 6 h after the intervention (T4). 2.3. Intervention
2.1. Design and participants This randomized controlled trial was conducted in 2018–2019 in the post-CA unit of Razi hospital, Birjand, Iran. Participants were patients who underwent CA in the study setting. Eligibility criteria were consent for participation, age of 30–60 years, transfemoral CA, no serious health problem in the feet, complete consciousness, normal dorsal pedal and posterior tibial pulses, no back pain during the last one week before CA, no back pain in the first back pain assessment after CA (immediately after admission), no affliction by known hemorrhagic disorders, no affliction by sensory disorders impairing back pain perception (such as paraplegia), no history of spinal surgery or herniated disk in the lower back, no inflammation or infection in the leg or the sole, and no use of opioid agents, tranquilizers, or anesthetics during the 4 h before and after CA. Exclusion criteria were any physiologic or hemodynamic instability during and after CA such as cardiac dysrhythmia or active bleeding at catheter insertion site. Sample size was calculated as 60 subjects per group with a type I error of 0.05, a power of 0.80, and a potential attrition rate of 15% and based on the results of previous study which reported two means of 1.62 � 2.75 and 0.34 � 1.16 [38]. To recruit the subjects, a post-CA unit personnel informed the first author when a candidate for CA was admitted to the post-CA unit. The researcher assessed whether the candidate met the inclusion criteria. The patients who met the criteria signed a written informed consent form. In total, 120 eligible patients were conveniently recruited to the study from September 2018 to March 2019. Afterwards, recruited
2.4. Ethical considerations This study was approved by the Ethics Committee of Birjand Uni versity of Medical Sciences (BUMS), Birjand, Iran (code: IR.BUMS. REC.1397.289) and was registered in the Iranian Registry of Clinical Trials (code: IRCT20190203042606N1). The aims of the study were explained to all eligible participants and they were ensured of 2
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Complementary Therapies in Clinical Practice 38 (2020) 101068
Fig. 1. The flow diagram of the study.
3. Results Initially, 120 patients were recruited to the study and equally allo cated to two groups. Two patients from the control group and two from the reflexology group were excluded due to loss to follow-up or volun tary withdrawal. Consequently, final data analysis was performed on the data collected from 116 patients—58 in each group (Fig. 1). Age mean in the control and the reflexology groups was 52.83 � 6.72 and 54.71 � 5.54, respectively. CA duration in these groups was 18.67 � 1.76 and 18.87 � 1.82, respectively. Moreover, body mass index in these groups was 25.28 � 5.1 and 23.87 � 4.1, respectively. There were no significant differences between these groups respecting participants’ age, CA duration, body mass index, gender, marital status, educational level, back pain history, and smoking history (P > 0.05; Table 1). The results of the Friedman test illustrated significant changes in the scores of back pain intensity in both groups across the five measurement time-points (P < 0.001; Table 2). Post hoc analysis using the Wilcoxon signed-rank test was used to compare T0 with other time points. Sta tistical analysis showed that in the control group, back pain intensity at all time points was significantly greater than T0 (P < 0.01), while in the
Fig. 2. Visual analogue scale.
confidential data management and voluntary participation in the study. Informed consent was gained from all participants. 2.5. Data analysis Data were analyzed at a significance level of 0.05 and using the SPSS software (v. 16.0). Data description was performed via the measures of descriptive statistics, including relative frequency, mean, and standard deviation. Normal distribution of the data was checked through the Kolmogorov-Smirnov test. Between-group comparisons respecting pain intensity were made using the Mann-Whitney U test. Within-group comparisons respecting the variations of pain intensity across the five measurement time-points were made using the Friedman test.
Box 1 The solar plexus and the spinal column reflex areas Solar plexus area is an oval area on the sole inscribed by an assumed triangle. One edge of this triangle is a line connecting the inferior edges of the pads below the big toe and the other toes. The other two edges are formed by drawing an assumed line along the outer edge of the big toe pad and the other along the inner edge of the other toes pad. Spinal column reflex area aligns with a narrow strip stretching from heels up to big toes [47,48].
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Table 1 Between-group comparisons respecting participants’ characteristics. Group Characteristics Gender Marital status Educational level
Back pain history Smoking history a b
Male Female Married Single Illiterate Primary Guidance school High school University Yes No Yes No
Control N (%)
Reflexology N (%)
P value
30 (51.7) 28 (48.3) 51 (87.9) 7 (12.1) 20 (34.5) 17 (29.3) 4 (6.9)
29 (50) 29 (50) 55 (94.8) 3 (5.2) 31 (53.4) 17 (29.3) 5 (8.6)
0.62a
12 (20.7) 5 (8.6) 17 (29.3) 41 (70.7) 11 (19) 47 (81)
3 (5.3) 2 (3.4) 24 (41.4) 34 (58.6) 12 (20.7) 46 (79.3)
0.31b 0.22b
0.28a 0.9a
The results of the Chi-square test. The results of the Fisher exact test. Fig. 3. Trends of pain intensity in control and reflexology groups over time.
reflexology group, pain intensity scores only at T3 and T4 were signif icantly greater than T0 (P < 0.01). Although the back pain intensity score at T4 was less than T3 in both groups, the scores were not significantly different (P > 0.05; Fig. 3). Between-group comparisons using the Mann-Whitney U test revealed that except for T0 (P ¼ 1.00), back pain intensity scores at the other four time-points in the reflexology group was significantly less than those of the control group (P < 0.01; Table 2).
reported any serious adverse effects including pain for this intervention [52]. Nonetheless, statistical analysis revealed that in the control group, there was a significant increased from T0 to T3, while in the reflexology group, back pain intensity was significantly greater only at T3 than T0. This difference between the two groups can be attributed to the foot reflexology effects. However, our findings showed that there was an exception to the general trend of back pain intensity in both groups. Back pain at T4 decreased more than T3 in both groups, although this decrease was not significant. The anticipation of complete bed rest termination might have changed patients’ pain perception at this time point and resulted in this finding. Personal background history (including expectations, per ceptions, and concerns) is a significant factor affecting the perceptions of a given circumstance [53]. Study findings also showed that despite insignificant between-groups difference respecting pain intensity at T0, pain intensity score in the control group was significantly higher than the reflexology group at T1–T4. In other words, patients in the reflexology group experienced significantly lower levels of back pain at T1–T4 compared with their counterparts in the control group. Several earlier studies also reported the positive effects of reflexology on pain. For instance, a study found that reflexology significantly reduced pain intensity among nurses with chronic back pain [54]. Another study found that 40-min single-foot reflexology applied once a week for six consecutive weeks was
4. Discussion This study aimed to evaluate the effects of foot reflexology on back pain after CA. Findings indicated that back pain intensity generally increased in both groups from T0 to T3. Similarly, a former study into the effects of positioning on post-CA back pain reported significant in crease in back pain intensity in both control and intervention groups during the first 6 h after CA [9]. Long-term bed rest in a fixed position increases tissue pressure, reduces blood supply to muscles and tissues, and thereby, causes muscle fatigue and weakness [49,50]. It can be supposed that as muscle fatigue and weakness increase, post-CA back pain intensifies in both groups from T0 to T3. Some researchers believe, however, that if reflexology is not performed correctly, it can lead to adverse effects including pain [51]. In our study, post-CA back pain scores increased from T0 to T3 in both groups, suggesting that the increased pain cannot be attributed to an incorrect application of foot reflexology. In fact, a systematic review on foot reflexology has not
Table 2 Within- and between-group comparisons respecting back pain score. Group Time
Reflexology
Test resultsa
Control
Median (IQR)
Mean (SD)
Median (IQR)
Mean (SD)
Immediately after admission
0.00 (0.00–0.00)
0.00 � 0.00
0.00 (0.00–0.00)
0.00 � 0.00
Twenty minutes after admission
0.00 (0.00–0.00)
0.00 � 0.00
0.00 (0.00–0.00)
6.12 � 16.23
Two hours after the intervention
0.00 (0.00–0.00)
4.83 � 15.72
0.00 (0.00–25.00)
15.62 � 23.50
Four hours after the intervention
0.00 (0.00–2.50)
7.52 � 15.91
0.00 (0.00–32.75)
17.19 � 25.29
Six hours after the intervention
0.00 (0.00–0.00)
5.78 � 13.63
0.00 (0.00–25.00)
15.84 � 24.43
b
Test results a b
2
2
χ ¼ 33.88; P < 0.001
χ ¼ 55.86; P < 0.001
Mann-Whitney U test results for comparison of the mean scores of the two groups at each time point. *: The results of the Friedman test. 4
Z ¼ 0.00 P¼1 Z ¼ 3.46 P < 0.001 Z ¼ 3.75 P < 0.001 Z ¼ 2.67 P < 0.01 Z ¼ 3.07 P < 0.01 –
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effective in significantly reducing back pain among patients with non-specific low back pain [55]. Foot reflexology was also reported to significantly reduce pain among patients with coronary artery bypass graft surgery [56], migraine [57], and metastatic cancers [58], as well as labor pain [59]. Although our study is different from these studies in population and reflexology protocol, the results of all these studies support our findings respecting the positive effects of reflexology on pain intensity. The positive effects of reflexology on pain can be explained in several ways. As mentioned earlier, bed rest in a fixed position for long hours can increase tissue pressure, reduce tissue and muscle blood supply, cause muscle fatigue, weakness, and spasm [49,50,57,60], and thereby, inflict back pain. An explanation for the positive effects of reflexology is hemodynamic theory which asserts that the stimulation of a point in an area of the body can increase blood flow to the corresponding body organ [61] and thereby, reduce pain in that organ. Another explanation for the positive effects of reflexology on back pain may be its effec tiveness in significantly reducing stress. Stress can have conflicting ef fects on pain perception, lower pain threshold, and reduce the ability to distract from pain stimuli [62]. Some former studies reported that reflexology can significantly reduce stress [63,64]. Stimulation of endorphin release is the other explanation for the positive effects of reflexology on pain. Through stimulating endorphin release, reflexology can promote well-being and relaxation and thereby, reduce pain [60, 65]. Previous research has shown that foot reflexology before CA can lead to improvements in the stress and vital signs of patients, including decreased diastolic blood pressure, heart rate, and respiratory rate [66]. Also, foot reflexology has been identified as a useful adjunct to the therapeutic regimen to decrease blood pressure in CAD patients [35]. Finally, this intervention could improve anxiety and sleep quality in CAD patients [34,36]. However, no research could be retrieved from valid scientific databases to have investigated the effects of foot reflex ology on post-CA back pain. The findings of this study can provide useful data for researchers to conduct evidence synthesis, such as meta-analysis, concerning the ef fects of foot reflexology on the back pain, especially post-CA back pain. Moreover, the study design and findings can guide investigators to design future work whereby the effect of foot reflexology on post-CA back pain can be tested. Among the strengths of the present study were its rigorous ran domized controlled design and the use of a valid and reliable tool for pain assessment. Nevertheless, this study has some limitations, including the single site of study and convenience sampling. Both of these can limit generalizability of findings. Moreover, this study was focused on patients aged 30–60. Future work is suggested to be done on different age groups of patients. Future studies are recommended to evaluate the effects the reflexology applied to other reflex points on back pain as well as the effects of other complementary therapies such as acupressure or auriculotherapy on post-CA back pain.
Declaration of competing interest The authors have no conflict of interests. Acknowledgement We would like to thank all participants of the study. This study was funded by the Deputy of Research, BUMS (contract ID¼455698). Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi. org/10.1016/j.ctcp.2019.101068. References [1] T.K. Wang, T.H. Oh, C.B. Samaranayake, M.W. Webster, J.T. Stewart, T. Watson, et al., The utility of a ’non-significant’ coronary angiogram, Int. J. Clin. Pract. 69 (12) (2015) 1465–1472. [2] L.L. Buzatto, S.S. Zanei, Patients’ anxiety before cardiac catheterization, Einstein (Sao Paulo). 8 (4) (2010) 483–487. [3] P.H. Caldwell, H.M. Arthur, M. Natarajan, S.S. Anand, Fears and beliefs of patients regarding cardiac catheterization, Soc. Sci. Med. 65 (2007) 1038–1048. [4] S. Schulz-Schüpke, S. Helde, S. Gewalt, T. Ibrahim, M. Linhardt, K. Haas, et al., Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial, Jama 312 (19) (2014) 1981–1987. [5] D.R. Tavris, B.A. Gallauresi, B. Lin, S.E. Rich, R.E. Shaw, W.S. Weintraub, et al., Risk of local adverse events following cardiac catheterization by hemostasis device use and gender, J. Invasive Cardiol. 16 (9) (2004) 459–464. [6] G. Ndrepepa, P.B. Berger, J. Mehilli, M. Seyfarth, F.-J. Neumann, A. Sch€ omig, et al., Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point, J. Am. Coll. Cardiol. 51 (7) (2008) 690–697. [7] S.C. Smeltzer, B.G. Bare, J.L. Hinkle, K.H. Cheever, Brunner and Suddarths Textbook of Medical and Surgical Nursing, 13th., Lippincott, NY, 2014. [8] M.H. Lund� en, A. Bengtson, S.M. Lundgren, Hours during and after coronary intervention and angiography, Clin. Nurs. Res. 15 (4) (2006) 274–289. [9] S.Y. Chair, R. Taylor-Pilia, G. Lam, S. Chan, Effect of positioning on back pain after coronary angiography, J. Adv. Nurs. 42 (2003) 470–478. [10] S.Y. Chair, D.R. Thompson, S.K. Li, Effect of ambulation after cardiac catheterization on patient outcomes, J. Clin. Nurs. 16 (2007) 212–214. [11] T.G. Pickering, Pain and blood pressure, J. Clin. Hypertens. 5 (5) (2003) 359–361. [12] Q. Lu, L.K. Zeltzer, G.C.I. Tsao, S.C. Kim, N. Turk, B.D. Nalibof, Heart rate mediation of sex differences in pain tolerance in children, Pain 118 (1–2) (2005) 185–193. [13] P.G. Morton, D.K. Fontaine, Critical Care Nursing a Holistic Approach, eighth ed., Lippincott Williams & Wilkins, Philadelphia, 2005. [14] G. Malanga, E. Wolff, Evidence-informed management of chronic low back pain with nonsteroidal anti-inflammatory drugs, muscle relaxants, and simple analgesics, Spine J. 8 (1) (2008) 173–184. [15] R. Benyamin, A.M. Trescot, S. Datta, et al., Opioid complications and side effects, Pain Physician 11 (2) (2008) S105–S120. [16] R. Benyamin, A.M. Trescot, S. Datta, R. Buenaventura, R. Adlaka, N. Sehgal, et al., Opioid complications and side effects, Pain Physician 11 (2 Suppl) (2008) S105–S120. [17] G. Malanga, E. Wolff, Evidence-informed management of chronic low back pain with nonsteroidal anti-inflammatory drugs, muscle relaxants, and simple analgesics, Spine J. 8 (1) (2008) 173–184. [18] A.K. Kanodia, A.T. Legedza, R.B. Davis, D.M. Eisenberg, R.S. Phillips, Perceivedbenefit of Complementary and Alternative Medicine (CAM) for back pain: a national survey, J. Am. Board Fam. Med. 23 (3) (2010) 354–362. [19] A.J. Vickers, A.M. Cronin, A.C. Maschino, G. Lewith, H. MacPherson, N.E. Foster, et al., Acupuncture for chronic pain: individual patient data meta-analysis, Arch. Intern. Med. 172 (19) (2012) 1444–1453. [20] K.L. Fontaine, Complementary and Alternative Therapies for Nursing Practice, Pearson Prentice Hall, NJ, 2005. [21] M.Y. Chang, S.Y. Wang, C.H. Chen, Effects of massage on pain and anxiety during labour: a randomized controlled trial in Taiwan, J. Adv. Nurs. 38 (1) (2002) 68–73. [22] T. Field, Pregnancy and labor massage, Expert Rev. Obstet. Gynecol. 5 (2) (2010) 177–181. [23] M.T. Nabb, L. Kimber, A. Haines, C. McCourt, Does regular massage from late pregnancy to birth decrease maternal pain perception during labour and birth? A feasibility study to investigate a programme of massage, controlled breathing and visualization, from 36 weeks of pregnancy until birth, Complement. Ther. Clin. Pract. 12 (3) (2006) 222–231. [24] T. Field, Massage therapy effects, Am. Psychol. 53 (12) (1998) 1270–1281. [25] E. Zwelling, K. Johnson, J. Allen, How to implement complementary therapies for laboring women, Am. J. Matern./Child Nurs. 31 (6) (2006) 364–370.
5. Conclusion This study concludes that as an easy-to-use non-invasive technique, reflexology can be used to significantly reduce back pain after CA. Author contributions SAV conceived of the initial idea for the study and helped to study design. MK designed the study, collected data, and performed the sta tistical analysis. BZ contributed to intervention design and to draft the manuscript. NA helped to recruit the participants. HRB helped to intervention design and to draft the manuscript. All authors read and approved the final manuscript.
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Complementary Therapies in Clinical Practice 38 (2020) 101068 [46] K.E. Roach, M.D. Brown, K.M. Dunigan, C.L. Kusek, M. Walas, Test-retest reliability of patient reports of low back pain, J. Orthop. Sport. Phys. Ther. 26 (5) (1997) 253–259. [47] World Health Organization, WHO Standard Acupuncture Point Locations in the Western Pacific Region. InWHO Standard Acupuncture Point Locations in the Western Pacific Region, 2008. [48] S. Andrews, B. Dempsey, Acupressure and Reflexology for Dummies, first ed., John Wiley & Sons, Canada, 2007. [49] A. Hadi, Y.H. Amin, Designing and constructing an optical monitoring system of blood supply to tissues under pressure, J. Med. Signals. Sens. 2 (2) (2012) 114–119. [50] J. H€ oglund, U. Stenestrand, T. T€ odt, I. Johansson, The effect of early mobilization forpatient undergoingcoronary angiography; a pilot study with focus on vascular complications and back pain, Eur. J. Cardiovasc. Nurs. 10 (2) (2011) 130–136. [51] N.H. Embong, Y.C. Soh, L.C. Ming, T.W. Wong, Perspectives on reflexology: a qualitative approach, J. Tradit., Complementary. Med. 7 (3) (2017) 327–331, 1. [52] J.E. McCullough, S.D. Liddle, M. Sinclair, C. Close, C.M. Hughes, The physiological and biochemical outcomes associated with a reflexology treatment: a systematic review, Evid. Based Complement Altern. Med. 2014 (2014) 502123. [53] P.E. Benner, J. Wrubel, The Primacy of Caring: Stress and Coping in Health and Illness, Addison-Wesley, CA, 1989. [54] M. Eghbali Babadi, F. Nazari, R. Safari, S. Abdoli, The effect of reflexology on pain perception aspects in nurses with chronic low back pain in Isfahan, Iran. J. Nurs. Midwifery Res. 21 (5) (2016) 487–492. [55] F. Quinn, C.M. Hughes, G.D. Baxter, Reflexology in the management of low back pain: a pilot randomised controlled trial, Complement. Ther. Med. 16 (1) (2008) 3–8. [56] M. Dolatian, A. Hasanpour, S.H. Montazeri, R. Heshmat, H. Alavi Majd, The effect of reflexology on pain intensity and duration of labor on primiparas, Iran. Red Crescent Med. J. 13 (7) (2011) 475–479. [57] W. Kobza, P. Lizis, H.R. Zięba, Effects of feet reflexology versus segmental massage in reducing pain and its intensity, frequency and duration of the attacks in females with migraine: a pilot study, J. Tradit. Chin. Med. 37 (2) (2017) 214–219. [58] N. Stephenson, J.A. Dalton, J. Carlson, The effect of foot reflexology on pain in patients with metastatic cancer, Appl. Nurs. Res. 16 (4) (2003) 284–286. [59] M. Valiani, E. Shiran, M. Kianpour, M. Hasanpour, Reviewing the effect of reflexology on the pain and certain features and outcomes of the labor on the primiparous women, Iran. J. Nurs. Midwifery Res. 15 (Suppl1) (2010) 302–310. [60] D. Tiran, Reflexology in Pregnancy and Childbirth, Churchill Livingstone Elsevier, London, UK, 2010. [61] E. Ingham, Stories the Feet Can Tell Thru Reflexology, Stories the Feet Have Told Thru Reflexology, Ingham Publishing, St Petersburg, Fla, USA, 1984. [62] A.K. Woo, Depression and anxiety in pain, Reviews in pain 4 (1) (2010) 8–12. [63] M. Soheili, F. Nazari, V. Shaygannejad, M. Valiani, A comparison the effects of reflexology and relaxation on the psychological symptoms in women with multiple sclerosis, J. Educ. Health Promot. 6 (2017) 11. [64] A.J. Mc Vicar, C.R. Greenwood, F. Fewell, V. D’arcy, S. Chandrasekharan, L. C. Alldridge, Evaluation of anxiety, salivary cortisol and melatonin secretion following reflexology treatment: a pilot study in healthy individuals, Complement. Ther. Clin. Pract. 13 (3) (2007) 137–145. [65] H. Poole, S. Glenn, P. Murphy, A randomised controlled study of reflexology for the management of chronic low back pain, Eur. J. Pain 11 (8) (2007) 878–887. [66] A. Kahaledifar, M. Nasiri, B. Khaledifar, A. Khaledifar, A. Mokhtari, The effect of reflexotherapy and massage therapy on vital signs and stress before coronary angiography: an open-label clinical trial, ARYA Atherosclerosis 13 (2) (2017) 50–55.
[26] A.T. Ferrell-Torry, O.J. Glick, The use of therapeutic massage as a nursing intervention to modify anxiety and the perception of cancer pain, Cancer Nurs. 16 (2) (1993) 93–101. [27] A. White, J. Williamson, A. Hart, E. Ernst, A blinded investigation into the accuracy of reflexologycharts, Complement. Ther. Med. 8 (3) (2000) 166–172. [28] B. Kunz, K. Kunz, Reflexology: Health at Your Fingertips, Dorling Kindersley, NY, 2003. [29] R. 27Xavier, Facts on reflexology (foot massage), Nurs. J. India 98 (1) (2007) 11–12. [30] H. Poole, S. Glenn, P. Murphy, A randomised controlled study of reflexology for the management of chronic lowback pain, Eur. J. Pain 11 (8) (2007) 878–887. [31] R. Barker, A. Kober, K. Hoerauf, D. Latzke, S. Adel, Z.N. Kain, et al., Out of hospital auricular acupressure in elder patients with hip fracture: a randomized double blinded trial, Acad. Emerg. Med. 13 (1) (2006) 19–23. [32] J.H. Yang, The effects of foot reflexology on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy, J. Kor. Acad. Nurs. 35 (1) (2005) 177–185. [33] N. Stephenson, S.P. Weinrich, A.S. Tavakolil, The effects of foot reflexology on anxiety and pain in patients with breast and lung cancer, Oncol. Nurs. Forum 27 (1) (2000) 67–72. [34] A. Rahmani, M. Naseri, M.M. Salaree, B. Nehrir, Comparing the effect of foot reflexology massage, foot bath and their combination on quality of sleep in patients with acute coronary syndrome, J. Caring Sci. 5 (4) (2016) 299–306. [35] W.A. Lu, G.Y. Chen, C.D. Kuo, Foot reflexology can increase vagal modulation, decrease sympathetic modulation, and lower blood pressure in healthy subjects and patients with coronary artery disease, Altern. Ther. Health Med. 17 (4) (2011) 8–14. [36] Z. Rahmani Vasokolaei, N. Rejeh, M. Heravi-Karimooi, S.D. Tadrisi, K. Saatchi, Z. Poshtchaman, et al., Comparison of the effects of hand reflexology versus acupressure on anxiety and vital signs in female patients with coronary artery diseases, Health Care 7 (1) (2019) E26, pii. [37] F. Quinn, G. Baxter, C.M. Hughes, Complementary therapies in the management of low back pain: a survey of reflexologists, Complement. Ther. Med. 16 (1) (2008) 9–14. [38] A.A. Abdollahi, S. Mehranfard, N. Behnampour, A.M. Kordnejad, Effect of positioning and early ambulation on coronary angiography complications: a randomized clinical trial, J. Caring Sci. 4 (2) (2015) 125–134. [39] A. Kelly, The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain, Emerg. Med. J. 18 (3) (2001) 205–207. [40] D. Jackson, S. Horn, P. Kersten, L. Turner-Stokes, Development of a pictorial scale of pain intensity for patients with communication impairments: initial validation in a general population, Clin. Med. 6 (6) (2006) 580–585. [41] J. Linacre, Visual analog scales, Rasch Meas Transactions 12 (1998) 639. [42] M. Koleck, J.M. Mazaux, N. Rascle, Schweitzer M. Bruchon, Psychosocial factors and coping strategies as predictors of chronic evolution and quality of life in patients with low back pain: a prospective study, Eur. J. Pain 10 (1) (2006) 1–11. [43] E.J. Bousema, J.A. Verbunt, H.A. Seelen, J.W. Vlaeyen, J.A. Knottnerus, Disuse and physical deconditioning in the first year after the onset of back pain, Pain 130 (3) (2007) 279–286. [44] H. Heneweer, G. Aufdemkampe, M.W. van Tulder, H. Kiers, K.H. Stappaerts, L. Vanhees, Psychosocial variables in patients with (sub) acute low back pain: an inception cohort in primary care physical therapy in The Netherlands, Spine 32 (5) (2007) 586–592. [45] E.J. Gallagher, P.E. Bijur, C. Latimer, W. Silver, Reliability and validity of a visual analog scale for acute abdominal pain in the ED, Am. J. Emerg. Med. 20 (4) (2002) 287–290.
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