Clinical trial NCT06642194: The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and Anxiety Among Patient Undegroing Hemodialysis
Official title: The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Quality
Fatigue
Anxiety
Depression
Lead sponsor: Universitas Muhammadiyah Yogyakarta
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study to examine the effects of implementation sunnah on sleeping on sleep quality, sleep time receiving a slow stroke back massage on fatigue and quality of life among participants undergoing maintenance hemodialysis will be applied. The study will be conducted at the hemodialysis unit of a medical center in a central part of Indonesia. To determine the sample size at a 95% confidence level and 80% test power, with a mean difference of at least 0.72 and a standard deviation of 1.22 in the intervention group and 1.22 in the control group, based on the study of \[17\] and according to the sample size formula, we determined a requirement of 205participants in each group. Forty participants were recruited and allocated to either the experimental group (n=25) or the control group (n = 25).

Participants will be recruited if they were: (i) 18 years of age or over; (ii) under- going hemodialysis for a minimum of three months; (iii) undergoing maintenance hemodialysis; (iv) diagnosed with a maximum of two comorbidities; (v) affiliated to Islam; and (vi) not hearing-impaired. Participants were excluded if they had, (i) muscle problems, and (3) unstable vital signs. A thorough review of participant charts will be performed to confirm they met the inclusion and exclusion criteria. Participants then will be randomly assigned to two different groups based on their hemodialysis schedule.

The measurement of demographic and illness-related characteristics; the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) and Pitssburg Sleep Quality Index (PSQI) will be conducted at the baseline and after the fourth week. The FACIT-fatigue scale was used to measure participant fatigue. FACIT-fatigue has 13 items to assess fatigue and its impact on functioning and daily activities in a number of chronic diseases, with five-point response options from 0 to 4. The total score ranges from 0 to 52, where a higher total score reflects less fatigue. The items include tiredness, listlessness, weakness, lack of energy, and impact on daily. In the study, we will use a validated Indonesian version of FACIT-fatigue. This version has been tested on 52 participants by Sihombing et al 2016 with CKD and has good internal reliability with a Cronbach's alpha of 0.62 (20). The PSQI has been translated and tested for validity and reliability by Setyowati \& Chung (2021). The Cronbach alpha for Indonesian version of PSQI is 0.72 which means that the Indonesian version of PSQI has adequate reliability (21).


Eligibility criteria: Inclusion Criteria:

Participants undergoing hemodialysis were recruited if they were: (1) 18 years of age or over; (2) undergoing maintenance hemodialysis twice a week for a minimum of three months; (3) affiliated to Islam, and (4) not hearing-impaired

Exclusion Criteria:

* Participants were excluded if they had unstable vital signs.

Primary outcomes:
measure: Sleep quality
timeFrame: Will be measured at base line and after three weeks, prior to hemodialysis procedure
measure: Fatigue
timeFrame: Will be measured at base line and after three weeks, prior to hemodialysis procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: RS PKU Muhammadiyah Yogyakarta
Study officials:
References: