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The effects of aromatherapy with lavender essential oil on fatigue levels in haemodialysis patients: A randomized clinical trial
Complementary Therapies in Clinical Practice 22 (2016) 33e37
Contents lists available at ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctcp
The effects of aromatherapy with lavender essential oil on fatigue levels in haemodialysis patients: A randomized clinical trial Masoumeh Bagheri-Nesami a, Seyed Afshin Shorofi a, b, Attieh Nikkhah a, *, Fatemeh Espahbodi c, Fahimeh-Sadat Ghaderi Koolaee d a
Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran Flinders University, Adelaide, Australia Department of Nephrology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran d Student Research Committee, Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 September 2015 Received in revised form 10 November 2015 Accepted 3 December 2015
Objective: This study was intended to examine the efficacy of lavender essential oil for the alleviation of fatigue in haemodialysis patients. Methods and materials: This randomized clinical trial was conducted on 59 haemodialysis patients in two groups. The routine care group received the routine care, but the experimental group inhaled lavender essence 5% for 10 min, three times a week for 4 consecutive weeks. The Fatigue Severity Scale was used to assess fatigue before the intervention and after the last intervention in the second and fourth weeks. Results: No statistically significant differences were observed between the two groups in terms of the fatigue scores before, and after the last intervention in the second and fourth weeks. Conclusion: Our result does not support other studies suggesting that lavender essential oil is effective on fatigue in haemodialysis patients. This conflicting result can mostly be ascribed to a variety of factors such as duration of aromatherapy and differences in concentrations of lavender essential oil. © 2015 Elsevier Ltd. All rights reserved.
Keywords: Aromatherapy Fatigue Fatigue Severity Scale Haemodialysis Lavender essential oil
1. Introduction The number of patients with end stage renal failure is on the rise [1]. These patients suffer from many other medical conditions and different problems. Fatigue is one of the most common side effects in haemodialysis patients and it adversely affects the patients' quality of life [2e5]. Most haemodialysis patients suffer from high scores of fatigue [4]. According to a research study by Gordon et al., one third of the patients reported that they feel worse in the first hour of haemodialysis. Furthermore, one quarter of the patients reported suffering from severe or very severe fatigue after haemodialysis [6]. In haemodialysis patients fatigue is thought to be caused by a combination of factors such as poor nutritional status [5], ageing, length of dialysis treatment [4] and reduced motivation [2]. It has been shown that fatigue is associated with symptoms such as sleep disturbances, depression, poor physical and health status in patients with renal failure requiring maintenance haemodialysis treatment [7]. A review of literature revealed several
* Corresponding author. E-mail address: [email protected] (A. Nikkhah). http://dx.doi.org/10.1016/j.ctcp.2015.12.002 1744-3881/© 2015 Elsevier Ltd. All rights reserved.
treatment options that can help relieve the symptoms of dialysisrelated fatigue, including oral vitamin C [8] and nonpharmacological methods such as back massage [9], exercise training [10] and yoga-based exercise [11]. A randomized controlled trial conducted on 106 participants examined the effectiveness of acupressure on fatigue in patients with end-stage renal-disease. Fatigue was measured using the revised Piper Fatigue Scale (PFS) and the Visual Analogue Scale for Fatigue (VAS-F). The study revealed the experimental group to have experienced less fatigue after the intervention compared to the control group [12]. Essential oil aromatherapy is another way to help alleviate fatigue. Essential oils are often extracted by steam distillation from aromatic plants [13]. Lavandula is a genus of over 30 species of flowering plants, including Lavandula angustifolia, Lavandula latifolia and Lavandula x intermedia [14]. Lavender essential oil originates from an herb and is used in various forms, including aromatherapy oil, gel, cream, lotion, infusion, and soap. In a randomized, double-blind, placebo controlled trial, patients were orally given 80 mg/day a preparation from Lavandula species or placebo for the treatment of subsyndromal anxiety disorder.
34
M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
Results showed the efficacy and safety of lavandula oil preparation for the relief of anxiety disorder [15]. Lavender can also be used as a cream. A study showed that a 3% cream of lavender, marjoram, black pepper and peppermint essential oils reduced neck pain [16]. In addition, lavender is used as an analgesic in traditional medicine, for massage therapy [17] and for inhalation therapy [18]. Research has confirmed that lavender produces sedative effects, promotes deep sleep [19], improves sleep quality [20], provides relaxing effects [21] and relives anxiety [22], which may offer relief from fatigue. Several studies have examined the fatigue-reducing effect of inhaling lavender essential oil. Kohara et al. (2004) found that combined modality treatment including aromatherapy, footsoak and reflexology can relieve fatigue in terminally ill cancer patients [23]. Furthermore, Lee (2000) examined the psychoneuroimmunology effect of aromatherapy massage and explored a significant decrease in fatigue scores following aromatherapy massage with 2% jojova oil mixed with lavender and rosemary oil for 20 min [24]. It has been also reported that lavender and eucalyptus inhalation can reduce fatigue in postpartum mothers [25]. As essential oils are fast-acting when inhaled and since patients are more receptive to trying natural therapies than traditional allopathic therapies, the present study was designed to help reduce fatigue in haemodialysis patients. To the best of our knowledge, no published study has explored the effects of lavender essential oil on fatigue in haemodialysis patients, so this study was intended to examine the efficacy of lavender essential oil for the alleviation of fatigue in haemodialysis patients. 2. Materials and methods 2.1. Sample and sampling method This randomized clinical trial was conducted in two hospitals affiliated to the Mazandaran University of Medical Sciences, Sari, Iran. Haemodialysis patients who met the following inclusion criteria were sampled: be willing to participate in the study, be treated with dialysis three times a week, be undergoing dialysis for at least six months [26], be of 18 years old and over, be conscious, have the ability to verbally communicate, and have an uncompromised sense of smell [27]. The exclusion criteria include patients with a history of allergies and respiratory diseases [27], kidney transplant candidates, pregnant women, and drug addicts. The sample size was calculated as 28 patients for each group according to the mean and standard deviation of fatigue, measured using the Fatigue Severity Scale, before the intervention (48.33 ± 15.90) and four weeks after the intervention (34.25 ± 14.79), found in a study conducted by Hadian and Asgharpour [28] and 95% confidence coefficient. With consideration of the likelihood of patient exclusion during the study, the final sample consisted of 30 patients in each group. The sample was randomly allocated in two groups using the Excel RANDBETWEEN function.
questionnaire in research studies [32]. The FSS includes nine items developed to measure the severity of fatigue symptoms experienced during the past week. Five items measure the quality of fatigue (items 1,2,3,4,6), 3 items measure physical and mental fatigue and the effect of fatigue on a person's social life (items 5,7,9), and one item (item 8) compares the severity of fatigue symptoms with each other. Each item is scored on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). A total score of 36 or more indicates severe fatigue, and higher scores suggest more severe fatigue [27]. Azimian et al. assessed internal consistency reliability and testeretest reliability of the Persian version of the scale using interclass correlation coefficient and Cronbach's alpha, respectively. The internal consistency reliability was reported 0.96, and testeretest reliability for the FSS total score was found to be 0.93. To evaluate the convergent validity of the scale, the correlation between FSS total score and VAS-fatigue score was analysed and indicated a high correlation (r ¼ 0.69, p < 0.0001) [33]. Demographic and medical data, including age, sex, length of haemodialysis treatment and underlying diseases, was collected using a questionnaire. 2.3. Ethical considerations This study was approved by the Medical Research and Ethical Committee of Mazandaran University of Medical Sciences. The study was also registered in the Iranian Registry of Clinical Trials (www.irct.ir) with the registration number: IRCT201407077494N9. Each participant was verbally provided with information regarding the study and the contents of the information sheet. All participants signed a consent form in which the study procedures were explained. 2.4. Procedure In our previous study, lavender essential oil with a concentration of 10% was inhaled for 5 min by patients on haemodialysis for needle insertion-related pain during 3 haemodialysis sessions [34]. We halved the concentration of the essential oil and doubled the exposure time in the current study. In other words, the experimental group inhaled lavender essence at a concentration of 5% for 10 min, three times a week (during dialysis sessions) for 4 consecutive weeks, while the other group received routine care. Whilst patients were in a semi-sitting position, a cotton ball soaked in 3 drops of lavender essential oil 5% (diluted 1:20 with sweet almond oil) was attached to each patient's collar and they were then asked to breathe slowly for 10 min. The essential oil was made with L. angustifolia and was produced by the Barij Essence Pharmaceutical Company (Kashan, Iran). Fatigue was measured using the Fatigue Severity Scale [29] in both groups for a total of three times (before the intervention, and after the last intervention in the second and fourth weeks) by only one researcher who was blind to the treatment allocation.
2.2. Measurement instruments 2.5. Data analysis There are several scales for the measurement of fatigue, such as the Fatigue Questionnaire (with 11 items for assessing the severity of fatigue in general practice settings), the Multidimensional Assessment of Fatigue (MAF) Scale (with 16 items for measuring self-reported fatigue in adults with rheumatoid arthritis), and the Modified Fatigue Impact Scale (MFIS; with 21 items for measuring fatigue in multiple sclerosis patients) [30,31]. Used in the current study, the Fatigue Severity Scale (FSS) is a general scale for measuring fatigue severity in a variety of medical and neurologic disorders [30]. A study comparing different fatigue measurement scales showed the FSS to be the most frequently used fatigue
Data was analysed with SPSS (Statistical Package for Social Science, version20) using descriptive statistics (mean, standard deviation and percentage), and analytical tests (Chi-square, independent t-test, repeated measurement test, Bonferroni test and KolmogoroveSmirnov test). 3. Results Only one patient from the experimental group was excluded because of an infection, resulting in 29 patients in the experimental
M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
35
Assessed for eligibility (n= 124)
Excluded (n=64) Not met inclusion criteria (n= 30) Declined to participate in the study (n= 34)
Randomized (n=60)
Allocation Allocated to control group (n=30)
Allocated to experimental group (n= 30)
Follow-Up
Without any participant withdrawals
Lost to follow-up (n= 1) due to infection
Analysis
Analysed (n= 30)
Analysed (n= 29)
Fig. 1. Consort flowchart.
group and 30 patients in the routine care group (See Fig. 1). The results showed that 17 (58.6%) of the experimental group and 21 (70%) of the routine care group were male. The mean age of patients was 62.31 ± 14.46 (range 31e88 years) and 59.33 ± 12.80 (range 30e85 years) in the experimental and routine care groups, respectively. The demographic and medical data of the participants are summarized in Table 1. The KolmogoroveSmirnov test showed a normal distribution in the experimental and routine care group for the fatigue score before, two and four weeks after the intervention (p > 0.05). The Bonferroni test confirmed no significant differences in two groups in terms of the fatigue score before, two and four weeks after the intervention (p > 0.05). The repeated measurement test was performed to compare the fatigue score in two groups before, two, and four weeks after the intervention (Table 2).
4. Discussion This study found that the fatigue score did not differ
significantly between the experimental and routine care groups before, two, and four weeks after the intervention. Bahraini et al. (2011) investigated the effects of effleurage massage with aromatic oil and non-aromatic oil on fatigue in patients with multiple sclerosis. Women with multiple sclerosis were divided into two massage therapy groups eone group with aromatic oil (10 ml of lavender essential oil 2.5%) and the other with non-aromatic oil (sweet almond oil). The patients were received massage for 20 min, 3 times a week, for 4 weeks. A statistically significant difference was found between the two groups in the severity of fatigue before and after the intervention [27]. This finding differs from our study possibly due to the differences in samples, doses and concentrations of lavender essential oil, duration and method of aromatherapy application. In another study, Kohara et al. (2004) reported a significant difference in total CFS (Cancer Fatigue Scale) scores before and after the intervention. They examined the effectiveness of combined modality treatment of aromatherapy, footsoak and reflexology on fatigue in patients with cancer in a semiexperimental study [23]. Contrary to Kohara et al.'s study, our
Table 1 Demographic and medical data of haemodialysis patients. Variable
Group Experimental group (n ¼ 29)
Control group (n ¼ 30)
p-value
Age Gender Male Female Underlying disease Diabetes and hypertension Diabetes Hypertension None Othera Kidney disease duration (months) Length of haemodialysis treatment (months)
62.31 ± 14.46
59.33 ± 12.80
0.27
58.6% 41.4%
70% 30%
0.36
31% 10.3% 26.6% 17.2% 14.9% 73.37 ± 74.92 42.48 ± 35.95
23.3% 13.3% 33.3% 13.3% 16.8% 83.1 ± 63.23 41.86 ± 27.69
0.81
a
Lupus erythematous, brain stroke and poisoning.
0.87 0.47
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M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
Table 2 Comparison of the mean score of fatigue before, two and four weeks after the intervention in the experimental and control groups. Fatigue
Before the intervention Two weeks after the intervention Four weeks after the intervention Repeated measurement test a
Group Experimental group (n ¼ 29) (Mean ± SE)a
Control group (n ¼ 30) (Mean ± SE)
45.24 ± 3.22 40.58 ± 3.55 42.61 ± 3.45 F ¼ 2.27, p ¼ 0.11 F ¼ 1.21, p ¼ 0.30
41.50 ± 3.17 42.13 ± 3.49 41.70 ± 3.39 F ¼ 0.03, p ¼ 0.96
Mean ± standard error.
patients inhaled lavender essential oil, which can explain our conflicting results. In a randomized controlled clinical trial, Hasankhani et al. (2013) investigated the effects of slow-stroke back massage on fatigue in haemodialysis patients. Fatigue was measured using the Piper Fatigue Scale. The experimental group received slow-stroke back massage for 10 min, three times a week for a period of four weeks. The control group, which was blind to the massage therapy, received its routine care. The results showed that massage can reduce fatigue in haemodialysis patients [9]. Massage is known to increase blood flow, delivery of oxygen and nutrients into the muscle and excretion of waste products. Additionally, massage can help relieve fatigue. Massage with lavender essential oil can enhance the effects of massage therapy [27] but aromatherapy massage requires training and more time can be taken than inhalation aromatherapy which does not need a great level of knowledge and skill for use in dialysis patients. We used diluted lavender essential oil, while pure lavender essential oil might have the potential to reduce fatigue in our patients. In a pretesteposttest nonequivalent control group design, Lee et al. (2004) assessed the effects of aroma inhalation on fatigue and sleep quality of postpartum mothers. Mothers wore a necklace with 10 drops of lavender oil and 10 drops of eucalyptus oil every day from 2 till 8 pm, between 1st and 5th postpartum day. Fatigue was measured using the Rhoten Fatigue Scale. This study demonstrated a significant difference in the fatigue score between the two groups after the intervention [25]. The results from the current study do not resemble those of Lee et al. due to the nature of the samples, duration of aromatherapy, differences in doses and concentrations of essential oils, essential oil blends, and two different methods for measurement of fatigue. A limitation of this study was the possible differences in dialysis adequacy indices among our participants as fatigue may be affected by dialysis adequacy. 5. Conclusion Although a few previous studies have demonstrated that lavender aromatherapy is an effective way to alleviate fatigue in dialysis patients, we found that lavender essential oil at a concentration of 5% does not positively affect fatigue levels in haemodialysis patients. This conflicting result can mostly be ascribed to multiple factors such as nature of the samples, duration of aromatherapy, differences in doses and concentrations of lavender essential oil, various routes of essential oil administration, essential oil blends, and adopted research methods. It is suggested that future studies investigate the effects of different doses, concentrations and administration routes of lavender essential oil with various types of research designs. Conflicts of interest The authors have no conflict of interest to declare.
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M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37 [25] S.H. Lee, Effects of aroma inhalation on fatigue and sleep quality of postpartum mothers, Korean J. Women Health Nurse 10 (3) (2004) 235e243. [26] M. Kanani, The effect of aromatherapy with orange essential oils on anxiety in patients undergoing hemodialysis, J. Sabzevar Univ. Med. Sci. 19 (3) (2012) 249e257 [Persian]. [27] S. Bahraini, A. Naji, R. Mannani, R. Bekhradi, The comparison of the effects of effleurage massage with aromatic oil and non-aromatic oil on fatigue severity in women with multiple sclerosis, J. Urmia Nurs. Midwifery Fac. 9 (5) (2011) 327e336 [Persian]. [28] Z. Hadian-Jazi, M. Aliasgharpoor, Evaluating the effects of designed exercise program on mean of activity tolerance in hemodialysis patients, J. Shahrekord Univ. Med. Sci. 14 (5) (2012) 83e91 [Persian]. [29] P.O. Valko, C.L. Bassetti, K.E. Bloch, U. Held, C.R. Baumann, Validation of the fatigue severity scale in a Swiss cohort, Sleep 31 (11) (2008) 1601e1607. [30] G.B. Neuberger, Measures of fatigue: the fatigue questionnaire, fatigue severity scale, multidimensional assessment of fatigue scale, and short form
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36 vitality (energy/fatigue) subscale of the short form health survey, Arthritis Care Res. 49 (S5) (2003) 175e183. N. Tellez, J. Rio, M. Tintore, C. Nos, I. Galan, X. Montalban, Does the modified fatigue impact scale offer a more comprehensive assessment of fatigue in MS? Mult. Scler. 11 (2) (2005) 198e202. N.H. Hjollund, J.H. Andersen, P. Bech, Assessment of fatigue in chronic disease: a bibliographic study of fatigue measurement scales, Health Qual. Life Outcomes 5 (2007) 12. M. Azimian, A.S. Farahani, A. Dadkhah, M. Fallahpour, M. Karimlu, Fatigue severity scale: the psychometric properties of the Persian-version in patients with multiple sclerosis, Res. J. Biol. Sci. 4 (9) (2009) 974e977. M. Bagheri-Nesami, F. Espahbodi, A. Nikkhah, S.A. Shorofi, J. Yazdani Charati, The effects of lavender aromatherapy on pain following needle insertion into a fistula in hemodialysis patients, Complement. Ther. Clin. Pract. 20 (1) (2014) 1e4.
Contents lists available at ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctcp
The effects of aromatherapy with lavender essential oil on fatigue levels in haemodialysis patients: A randomized clinical trial Masoumeh Bagheri-Nesami a, Seyed Afshin Shorofi a, b, Attieh Nikkhah a, *, Fatemeh Espahbodi c, Fahimeh-Sadat Ghaderi Koolaee d a
Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran Flinders University, Adelaide, Australia Department of Nephrology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran d Student Research Committee, Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 September 2015 Received in revised form 10 November 2015 Accepted 3 December 2015
Objective: This study was intended to examine the efficacy of lavender essential oil for the alleviation of fatigue in haemodialysis patients. Methods and materials: This randomized clinical trial was conducted on 59 haemodialysis patients in two groups. The routine care group received the routine care, but the experimental group inhaled lavender essence 5% for 10 min, three times a week for 4 consecutive weeks. The Fatigue Severity Scale was used to assess fatigue before the intervention and after the last intervention in the second and fourth weeks. Results: No statistically significant differences were observed between the two groups in terms of the fatigue scores before, and after the last intervention in the second and fourth weeks. Conclusion: Our result does not support other studies suggesting that lavender essential oil is effective on fatigue in haemodialysis patients. This conflicting result can mostly be ascribed to a variety of factors such as duration of aromatherapy and differences in concentrations of lavender essential oil. © 2015 Elsevier Ltd. All rights reserved.
Keywords: Aromatherapy Fatigue Fatigue Severity Scale Haemodialysis Lavender essential oil
1. Introduction The number of patients with end stage renal failure is on the rise [1]. These patients suffer from many other medical conditions and different problems. Fatigue is one of the most common side effects in haemodialysis patients and it adversely affects the patients' quality of life [2e5]. Most haemodialysis patients suffer from high scores of fatigue [4]. According to a research study by Gordon et al., one third of the patients reported that they feel worse in the first hour of haemodialysis. Furthermore, one quarter of the patients reported suffering from severe or very severe fatigue after haemodialysis [6]. In haemodialysis patients fatigue is thought to be caused by a combination of factors such as poor nutritional status [5], ageing, length of dialysis treatment [4] and reduced motivation [2]. It has been shown that fatigue is associated with symptoms such as sleep disturbances, depression, poor physical and health status in patients with renal failure requiring maintenance haemodialysis treatment [7]. A review of literature revealed several
* Corresponding author. E-mail address: [email protected] (A. Nikkhah). http://dx.doi.org/10.1016/j.ctcp.2015.12.002 1744-3881/© 2015 Elsevier Ltd. All rights reserved.
treatment options that can help relieve the symptoms of dialysisrelated fatigue, including oral vitamin C [8] and nonpharmacological methods such as back massage [9], exercise training [10] and yoga-based exercise [11]. A randomized controlled trial conducted on 106 participants examined the effectiveness of acupressure on fatigue in patients with end-stage renal-disease. Fatigue was measured using the revised Piper Fatigue Scale (PFS) and the Visual Analogue Scale for Fatigue (VAS-F). The study revealed the experimental group to have experienced less fatigue after the intervention compared to the control group [12]. Essential oil aromatherapy is another way to help alleviate fatigue. Essential oils are often extracted by steam distillation from aromatic plants [13]. Lavandula is a genus of over 30 species of flowering plants, including Lavandula angustifolia, Lavandula latifolia and Lavandula x intermedia [14]. Lavender essential oil originates from an herb and is used in various forms, including aromatherapy oil, gel, cream, lotion, infusion, and soap. In a randomized, double-blind, placebo controlled trial, patients were orally given 80 mg/day a preparation from Lavandula species or placebo for the treatment of subsyndromal anxiety disorder.
34
M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
Results showed the efficacy and safety of lavandula oil preparation for the relief of anxiety disorder [15]. Lavender can also be used as a cream. A study showed that a 3% cream of lavender, marjoram, black pepper and peppermint essential oils reduced neck pain [16]. In addition, lavender is used as an analgesic in traditional medicine, for massage therapy [17] and for inhalation therapy [18]. Research has confirmed that lavender produces sedative effects, promotes deep sleep [19], improves sleep quality [20], provides relaxing effects [21] and relives anxiety [22], which may offer relief from fatigue. Several studies have examined the fatigue-reducing effect of inhaling lavender essential oil. Kohara et al. (2004) found that combined modality treatment including aromatherapy, footsoak and reflexology can relieve fatigue in terminally ill cancer patients [23]. Furthermore, Lee (2000) examined the psychoneuroimmunology effect of aromatherapy massage and explored a significant decrease in fatigue scores following aromatherapy massage with 2% jojova oil mixed with lavender and rosemary oil for 20 min [24]. It has been also reported that lavender and eucalyptus inhalation can reduce fatigue in postpartum mothers [25]. As essential oils are fast-acting when inhaled and since patients are more receptive to trying natural therapies than traditional allopathic therapies, the present study was designed to help reduce fatigue in haemodialysis patients. To the best of our knowledge, no published study has explored the effects of lavender essential oil on fatigue in haemodialysis patients, so this study was intended to examine the efficacy of lavender essential oil for the alleviation of fatigue in haemodialysis patients. 2. Materials and methods 2.1. Sample and sampling method This randomized clinical trial was conducted in two hospitals affiliated to the Mazandaran University of Medical Sciences, Sari, Iran. Haemodialysis patients who met the following inclusion criteria were sampled: be willing to participate in the study, be treated with dialysis three times a week, be undergoing dialysis for at least six months [26], be of 18 years old and over, be conscious, have the ability to verbally communicate, and have an uncompromised sense of smell [27]. The exclusion criteria include patients with a history of allergies and respiratory diseases [27], kidney transplant candidates, pregnant women, and drug addicts. The sample size was calculated as 28 patients for each group according to the mean and standard deviation of fatigue, measured using the Fatigue Severity Scale, before the intervention (48.33 ± 15.90) and four weeks after the intervention (34.25 ± 14.79), found in a study conducted by Hadian and Asgharpour [28] and 95% confidence coefficient. With consideration of the likelihood of patient exclusion during the study, the final sample consisted of 30 patients in each group. The sample was randomly allocated in two groups using the Excel RANDBETWEEN function.
questionnaire in research studies [32]. The FSS includes nine items developed to measure the severity of fatigue symptoms experienced during the past week. Five items measure the quality of fatigue (items 1,2,3,4,6), 3 items measure physical and mental fatigue and the effect of fatigue on a person's social life (items 5,7,9), and one item (item 8) compares the severity of fatigue symptoms with each other. Each item is scored on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). A total score of 36 or more indicates severe fatigue, and higher scores suggest more severe fatigue [27]. Azimian et al. assessed internal consistency reliability and testeretest reliability of the Persian version of the scale using interclass correlation coefficient and Cronbach's alpha, respectively. The internal consistency reliability was reported 0.96, and testeretest reliability for the FSS total score was found to be 0.93. To evaluate the convergent validity of the scale, the correlation between FSS total score and VAS-fatigue score was analysed and indicated a high correlation (r ¼ 0.69, p < 0.0001) [33]. Demographic and medical data, including age, sex, length of haemodialysis treatment and underlying diseases, was collected using a questionnaire. 2.3. Ethical considerations This study was approved by the Medical Research and Ethical Committee of Mazandaran University of Medical Sciences. The study was also registered in the Iranian Registry of Clinical Trials (www.irct.ir) with the registration number: IRCT201407077494N9. Each participant was verbally provided with information regarding the study and the contents of the information sheet. All participants signed a consent form in which the study procedures were explained. 2.4. Procedure In our previous study, lavender essential oil with a concentration of 10% was inhaled for 5 min by patients on haemodialysis for needle insertion-related pain during 3 haemodialysis sessions [34]. We halved the concentration of the essential oil and doubled the exposure time in the current study. In other words, the experimental group inhaled lavender essence at a concentration of 5% for 10 min, three times a week (during dialysis sessions) for 4 consecutive weeks, while the other group received routine care. Whilst patients were in a semi-sitting position, a cotton ball soaked in 3 drops of lavender essential oil 5% (diluted 1:20 with sweet almond oil) was attached to each patient's collar and they were then asked to breathe slowly for 10 min. The essential oil was made with L. angustifolia and was produced by the Barij Essence Pharmaceutical Company (Kashan, Iran). Fatigue was measured using the Fatigue Severity Scale [29] in both groups for a total of three times (before the intervention, and after the last intervention in the second and fourth weeks) by only one researcher who was blind to the treatment allocation.
2.2. Measurement instruments 2.5. Data analysis There are several scales for the measurement of fatigue, such as the Fatigue Questionnaire (with 11 items for assessing the severity of fatigue in general practice settings), the Multidimensional Assessment of Fatigue (MAF) Scale (with 16 items for measuring self-reported fatigue in adults with rheumatoid arthritis), and the Modified Fatigue Impact Scale (MFIS; with 21 items for measuring fatigue in multiple sclerosis patients) [30,31]. Used in the current study, the Fatigue Severity Scale (FSS) is a general scale for measuring fatigue severity in a variety of medical and neurologic disorders [30]. A study comparing different fatigue measurement scales showed the FSS to be the most frequently used fatigue
Data was analysed with SPSS (Statistical Package for Social Science, version20) using descriptive statistics (mean, standard deviation and percentage), and analytical tests (Chi-square, independent t-test, repeated measurement test, Bonferroni test and KolmogoroveSmirnov test). 3. Results Only one patient from the experimental group was excluded because of an infection, resulting in 29 patients in the experimental
M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
35
Assessed for eligibility (n= 124)
Excluded (n=64) Not met inclusion criteria (n= 30) Declined to participate in the study (n= 34)
Randomized (n=60)
Allocation Allocated to control group (n=30)
Allocated to experimental group (n= 30)
Follow-Up
Without any participant withdrawals
Lost to follow-up (n= 1) due to infection
Analysis
Analysed (n= 30)
Analysed (n= 29)
Fig. 1. Consort flowchart.
group and 30 patients in the routine care group (See Fig. 1). The results showed that 17 (58.6%) of the experimental group and 21 (70%) of the routine care group were male. The mean age of patients was 62.31 ± 14.46 (range 31e88 years) and 59.33 ± 12.80 (range 30e85 years) in the experimental and routine care groups, respectively. The demographic and medical data of the participants are summarized in Table 1. The KolmogoroveSmirnov test showed a normal distribution in the experimental and routine care group for the fatigue score before, two and four weeks after the intervention (p > 0.05). The Bonferroni test confirmed no significant differences in two groups in terms of the fatigue score before, two and four weeks after the intervention (p > 0.05). The repeated measurement test was performed to compare the fatigue score in two groups before, two, and four weeks after the intervention (Table 2).
4. Discussion This study found that the fatigue score did not differ
significantly between the experimental and routine care groups before, two, and four weeks after the intervention. Bahraini et al. (2011) investigated the effects of effleurage massage with aromatic oil and non-aromatic oil on fatigue in patients with multiple sclerosis. Women with multiple sclerosis were divided into two massage therapy groups eone group with aromatic oil (10 ml of lavender essential oil 2.5%) and the other with non-aromatic oil (sweet almond oil). The patients were received massage for 20 min, 3 times a week, for 4 weeks. A statistically significant difference was found between the two groups in the severity of fatigue before and after the intervention [27]. This finding differs from our study possibly due to the differences in samples, doses and concentrations of lavender essential oil, duration and method of aromatherapy application. In another study, Kohara et al. (2004) reported a significant difference in total CFS (Cancer Fatigue Scale) scores before and after the intervention. They examined the effectiveness of combined modality treatment of aromatherapy, footsoak and reflexology on fatigue in patients with cancer in a semiexperimental study [23]. Contrary to Kohara et al.'s study, our
Table 1 Demographic and medical data of haemodialysis patients. Variable
Group Experimental group (n ¼ 29)
Control group (n ¼ 30)
p-value
Age Gender Male Female Underlying disease Diabetes and hypertension Diabetes Hypertension None Othera Kidney disease duration (months) Length of haemodialysis treatment (months)
62.31 ± 14.46
59.33 ± 12.80
0.27
58.6% 41.4%
70% 30%
0.36
31% 10.3% 26.6% 17.2% 14.9% 73.37 ± 74.92 42.48 ± 35.95
23.3% 13.3% 33.3% 13.3% 16.8% 83.1 ± 63.23 41.86 ± 27.69
0.81
a
Lupus erythematous, brain stroke and poisoning.
0.87 0.47
36
M. Bagheri-Nesami et al. / Complementary Therapies in Clinical Practice 22 (2016) 33e37
Table 2 Comparison of the mean score of fatigue before, two and four weeks after the intervention in the experimental and control groups. Fatigue
Before the intervention Two weeks after the intervention Four weeks after the intervention Repeated measurement test a
Group Experimental group (n ¼ 29) (Mean ± SE)a
Control group (n ¼ 30) (Mean ± SE)
45.24 ± 3.22 40.58 ± 3.55 42.61 ± 3.45 F ¼ 2.27, p ¼ 0.11 F ¼ 1.21, p ¼ 0.30
41.50 ± 3.17 42.13 ± 3.49 41.70 ± 3.39 F ¼ 0.03, p ¼ 0.96
Mean ± standard error.
patients inhaled lavender essential oil, which can explain our conflicting results. In a randomized controlled clinical trial, Hasankhani et al. (2013) investigated the effects of slow-stroke back massage on fatigue in haemodialysis patients. Fatigue was measured using the Piper Fatigue Scale. The experimental group received slow-stroke back massage for 10 min, three times a week for a period of four weeks. The control group, which was blind to the massage therapy, received its routine care. The results showed that massage can reduce fatigue in haemodialysis patients [9]. Massage is known to increase blood flow, delivery of oxygen and nutrients into the muscle and excretion of waste products. Additionally, massage can help relieve fatigue. Massage with lavender essential oil can enhance the effects of massage therapy [27] but aromatherapy massage requires training and more time can be taken than inhalation aromatherapy which does not need a great level of knowledge and skill for use in dialysis patients. We used diluted lavender essential oil, while pure lavender essential oil might have the potential to reduce fatigue in our patients. In a pretesteposttest nonequivalent control group design, Lee et al. (2004) assessed the effects of aroma inhalation on fatigue and sleep quality of postpartum mothers. Mothers wore a necklace with 10 drops of lavender oil and 10 drops of eucalyptus oil every day from 2 till 8 pm, between 1st and 5th postpartum day. Fatigue was measured using the Rhoten Fatigue Scale. This study demonstrated a significant difference in the fatigue score between the two groups after the intervention [25]. The results from the current study do not resemble those of Lee et al. due to the nature of the samples, duration of aromatherapy, differences in doses and concentrations of essential oils, essential oil blends, and two different methods for measurement of fatigue. A limitation of this study was the possible differences in dialysis adequacy indices among our participants as fatigue may be affected by dialysis adequacy. 5. Conclusion Although a few previous studies have demonstrated that lavender aromatherapy is an effective way to alleviate fatigue in dialysis patients, we found that lavender essential oil at a concentration of 5% does not positively affect fatigue levels in haemodialysis patients. This conflicting result can mostly be ascribed to multiple factors such as nature of the samples, duration of aromatherapy, differences in doses and concentrations of lavender essential oil, various routes of essential oil administration, essential oil blends, and adopted research methods. It is suggested that future studies investigate the effects of different doses, concentrations and administration routes of lavender essential oil with various types of research designs. Conflicts of interest The authors have no conflict of interest to declare.
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