As a randomized controlled trial, this study was undertaken in 2016 in the hemodialysis unit of Shahid Chamran hospital, Ferdows, Iran. The sample size was calculated using the sample size calculation formula for comparisons of two means. Based on the results of an earlier study in Iran, which reported two comfort mean scores of 35.64 ± 6.9 and 47.36 ± 6.98, and with a confidence level of 95%, eight persons were estimated for each group of the study. Nonetheless, the sample size was increased to twenty for each group in order to improve the power of the study. Sampling was done conveniently based on the following criteria: an age of 18 - 70, a thrice-weekly dialysis history of more than six months, complete consciousness, ability to communicate verbally, and no skin lesions on the back. Exclusion criteria were alterations in the level of consciousness or in the ability to communicate, changes in treatments, and voluntary withdrawal from the study. For random allocation, the names of the patients who referred to the study setting in odd and even weekdays were independently listed and then, one list was randomly allocated to the control group and the other to the intervention group.
A demographic questionnaire (including items on patients’ age, gender, marital status, educational status, and place of residence) and the short form of hospice comfort questionnaire (HCQ) were used for data gathering. Developed by Katharine Kolcaba (
34), HCQ contains 24 items in the following four dimensions: physical (5 items), psychospiritual (10 items), social (4 items), and environmental (5 items). Item scoring is done on a six-point Likert-type scale from 1 (“Strongly disagree”) to 6 (“Strongly agree”). Items 2, 4, 7, 11, 13, 14, 15, 18, 19, and 22 - 24 are scored reversely. The possible total scores of the physical, psychospiritual, social, and environmental dimensions and the total HCQ score are 5 - 30, 10 - 60, 4 - 24, 5 - 30, and 24 - 144, respectively. With Cronbach’s alpha values of 0.65 - 0.85, this questionnaire has an acceptable reliability (
13,
34).
Initially, HCQ was completed for all patients. The results showed that the most common comfort needs of patients were related to muscle cramps, headache, back pain, nausea, lack of knowledge about arteriovenous fistula care, dietary and treatment regimens, itching, rest and sleep disorders, and impaired comfort. Patients in the intervention group received back massage and patient and family education in six sessions on their hemodialysis days. The sessions were held every other day for two consecutive weeks. Back massage was provided based on the techniques proposed in the textbook fundamental of nursing (
35). Accordingly, at the end of each hemodialysis session, the second author used room-dividers and curtains to create a private environment for the back massage. Then, she placed the patient in the lateral position and exposed patient’s back for the massage. After that, she washed her hands with warm water and used baby oil to provide back massage in the following steps. Initially, she massaged the shoulders, back, and sacral area using gentle friction movements. Then, she placed her hands next to each other at the button of the spine and massaged the back from buttocks to shoulders and vice versa again using gentle friction movements. The bony prominences, such as the iliac spine and the sacrum, were massaged with circular movements. After that, the different areas of the back were compressed gently. Finally, baby oil was cleaned from the back and the patient was placed in the supine position. Back massage was performed for fifteen minutes. For male patients, back massage was provided by a male colleague. At the beginning of the study, the second author and her male colleague performed the back massage technique in presence of three faculty members of the fundamentals of nursing department of Birjand faculty of nursing and midwifery, Birjand, Iran. The faculty members approved the proper performance of the technique.
Besides back massage, need-based educations were provided to each patient and his/her family member during each hemodialysis session. Educations were based on the determined educational needs regarding the management of itching and muscle cramps, improvement of sleeping, skin care, fistula care, and adherence to dietary and treatment regimens. Educations were provided using the lecture method and a pamphlet. Each educational session was usually held before the back massage and lasted 15 - 20 minutes. The content of educations was approved by an attending physician. Patients in the control group received the routine care services of the study setting. At the end of the sixth session, HCQ was re-completed for all patients in both groups.
The aim of the study was explained to all participants and their informed consent was secured. Moreover, after the posttest, the educational pamphlet was provided to patients in the control group and their family members for the sake of ethical practice.
The data were analyzed via the SPSS software (v. 18.0). Primarily, the Kolmogorov-Smirnov test was run for normality testing. The measures of descriptive statistics (such as mean, standard deviation, and absolute and relative frequencies) were employed to present the data. The paired- and the independent-sample t tests were respectively run for within- and between-group comparisons respecting the mean scores of comfort and its subscales. The significance level was set at less than 0.05.