This was a single-blind clinical trial with a pretest-posttest design. The study population included all patients undergoing hemodialysis presenting to Ali ibn Abi Talib hospital in Zahedan, Iran, in 2017. The inclusion criteria were having at least 18 years of age, having a history of at least 6 months of hemodialysis, being on the weekly dialysis list, undergoing three to four hour sessions of dialysis each week, being able to communicate both verbally and in written form, not having any physical conditions hampering the intervention, not having any underlying conditions with severe fatigue as a symptom, and not being diagnosed with multiple sclerosis or other central and peripheral nervous system disorders in which the patient suffers from neuromuscular impairments. The exclusion criteria comprised receiving blood products and drugs such as calcitriol and venoflex during the intervention.
The sample size was estimated to be 42.45 persons in each group, using the formula for determining the sample size, taking into account 95% confidence, the test power of 90%, and based on the values obtained in the study by Shaer Moghadam et al. (
18). Due to the probability of sample attrition, 45 patients were assigned to each group, and thus 90 patients were enrolled in total.
Initially, the convenience sampling method was used. The subjects were selected randomly from the eligible patients presenting to Ali ibn Abi Talib hospital. Then, they were randomly assigned to two groups of intervention and control, such that by flipping a coin, the first person was assigned to a group, and the rest of the participants were alternately assigned to one of the groups.
After obtaining the code of ethics (IR.ZAUMS.REC.1396155) from the ethics committee of Zahedan University of Medical Sciences, the researcher presented to Ali ibn Abi Talib hospital of Zahedan, and after explaining the study procedure and obtaining informed consent from both groups, the fatigue scale was completed through interviews at the beginning, during, and at most half an hour after the onset of dialysis (as pre-test). The questionnaire was devised by Krupp et al. (1989) to examine fatigue in hemodialysis patients. This scale contains nine items rated using a 7-point Likert scale (totally agree to totally disagree). The minimum and maximum scores were 9 and 63, respectively, with higher scores indicating a higher level of fatigue. This questionnaire has been translated and validated in Iran (Cronbach’s alpha: 0.96) (
19). The person completing the questionnaire was not a reflective massage practitioner and was blinded to study groups.
In the intervention group, the researcher massaged both feet of each patient (each foot for 15 minutes) for half an hour, in total, using a reflective massage. In this method, the patient lied in the supine position with 30° head bed elevation and the ambient noise was minimized. The hands of the researcher were warmed before the intervention and any metal items such as ring were removed. The patient’s foot was completely in the hands of the researcher. The researcher sat on a chair that was parallel to the patient’s feet. Then, under the patient’s toes in the area of the kidneys (in areas 2 and 3 in the midline of the foot), massage was performed for 15 minutes for each foot. The massage was initiated with the right foot, and the overall process lasted for 30 minutes. This intervention was performed once a session for three consecutive dialysis sessions. The massage was given by a trained practitioner using thumbs in the form of sliding and gliding movements and pressure, such that resistance and stiffness were felt under the thumb. The pressure was exerted on the solar plexus point of the foot at the point that affected the kidneys. This method was adopted from valid sources (
15).
At the end of the dialysis sessions, the fatigue questionnaire was completed at post-test. The massage was performed for three consecutive sessions in the intervention group. In the control group, fatigue was evaluated at the beginning and at the end of dialysis using the instrument.
The data were coded and analyzed using SPSS version 21. First, frequency, percentage, mean, standard deviation, minimum, and maximum were determined by descriptive statistics. Then, for comparison of pre- and post-intervention means in each group, paired t-test, and for comparing the means of the intervention and control groups, independent t-test was run. Comparison of the frequency of qualitative variables in the two groups was made by using the chi-square test, and to determine the effect of reflective massage, independent t-test and paired t-test were performed. The significance level was set at 0.05.