This clinical trial was approved by the Vice-President of Research Information Technology and the Ethics Committee of Zabol University of Medical Sciences (Id: zbmu.1.REC.1396.184) and it complied with EMEA guidelines (
24).
The study was performed on 60 patients (from 120 patients) who had been admitted between January and March 2017 to the Special Patients Clinic, Zabol, the southeast of Iran. Using Cho’s study (
18), the sample size was estimated at 20 for each group within a 99% confidence level and statistical power of 95%. Patients were randomized into three groups, including acupressure (n = 20), reflexology (n = 20), and control (n = 20). The inclusion criteria were no stressful event in the past year (e.g. death of a close relative), no severe depression and anxiety, a minimum age of 18 years, minimum hemodialysis duration of six months, and undergoing dialysis three times a week (each lasting for four hours). The exclusion criteria, on the other hand, were amputations at the place of acupressure and foot reflexology, unwillingness to participate, lupus and chronic physical and psychological illnesses such as cancer, and having taken sedative drugs like benzodiazepines at least one month before the intervention. All qualified patients were informed of the purpose of the study and their consent was obtained. At the time of patients’ admission, after checking the medical history and performing required examinations, the researcher invited the willing eligible subjects to participate in the study. Sampling continued until the target sample size reached. To prevent the two groups from any contact that might lead patients to know about their respective types of intervention, the sampling days were divided into two sets using a random number table. Thus, reflexology was scheduled for even days and acupressure was planned on odd days. Once sampling was completed for the intervention groups, it was carried out for the control group.
Data collection consisted of three parts. The first part included a demographic questionnaire (age, gender, marital status, education level, employment status, number of dialysis sessions per week, and the primary cause of hemodialysis). The second part included the Spielberger State-Trait anxiety inventory (STAI). This 40-item questionnaire is scored between 20 and 80. Spielberger et al. (
25) reported the Cronbach’s alpha for the anxiety subscale to be 0.92. The validity and reliability of this tool have been confirmed in many studies (
5,
7,
8). Also, the test-retest coefficient for the anxiety subscale was 0.62 (
26). Finally, the third part was the Beck depression inventory-II (BDI-II). This questionnaire has 21 items, each graded from 0 to 3. The scores obtained are interpreted as follows: scores 0 - 13 indicate no or minimum depression, scores 14 - 19 represent mild depression, scores 20 - 28 suggest moderate depression, and scores 29 - 63 show severe depression. The convergent validity of BDI-II with the Hamilton depression rating scale (HDRS) was found to be 0.71. The test-retest reliability of this questionnaire was positively reported after one week (0.93) (
27).
The subjects were provided with necessary explanations about the intervention and its harmlessness; they were assured of the confidentiality of their information; then, their informed written consent was obtained. For those in the acupressure group, point P6 was used for the intervention.
This point is between the bones of the forearm in the width of three fingers above the wrist. After STAI and BDI-II were filled out, the research subjects were studied. One hour after starting dialysis, three days a week for four weeks, acupressure was performed rotationally (two rounds a second) at a pressure of 3 - 4 kg for eight minutes (
28). The correctness of the pressure was confirmed when the person felt warm, swollen, and heavy (
11). In the reflexology group, one hour after starting dialysis, the patient was put in the supine position; then, the thumb was pushed directly on the solar network point for 10 min for each foot. For four weeks, this was carried out rotationally, at a pressure of 3 - 4 kg, and three times a week (
23). To prevent hypotension during the massage, patients were asked to lie down on the left side. It should be noted that both interventions were performed by two nurses (authors) under the supervision of a CAM specialist. Four weeks after both interventions, the questionnaires were completed by the patients for the second time.
Patients in the control group received no intervention apart from their routine treatment. They yet filled out the questionnaires before and after the program. The collected data were analyzed in SPSS 19 using ANOVA, paired t-test, and post hoc test at a significance level of 0.05.