Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
The Effectiveness of Sunnah on Sleeping on Sleep Quality Fatigue Depression and Anxiety Among Patient Undegroing Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Sunnah on Sleeping on Sleep Quality Fatigue Depression and
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
sleeping
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 072 and a standard deviation of 122 in the intervention group and 122 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 n25 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 Cronbachs alpha of 062 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 072 which means that the Indonesian version of PSQI has adequate reliability 21
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 Cronbachs alpha of 062 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 072 which means that the Indonesian version of PSQI has adequate reliability 21
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None