Sleep QualitysleepingNCT06642194
The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and Anxiety Among Patient Undegroing Hemodialysis
A study testing Education on sunnah of sleeping in people with Sleep Quality and Fatigue, run by Universitas Muhammadiyah Yogyakarta at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Fatigue, Anxiety
- What is being tested?
- Education on sunnah of sleeping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 May 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants were excluded if they had unstable vital signs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and
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).
- Conditions
- Sleep Quality, Fatigue, Anxiety, Depression
- Being tested
- Education on sunnah of sleeping
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on sunnah of sleepingBehavioural
The interventions had three session which conducted between 40-60 minutes per session. The session include: 1) introducing the research objectives, definition and benefits on sunnah of sleeping; 2) steps in sunnah of sleeping (early bedtime and early wake up time; perform ablution (wudoo) before going to bed and supplicate; dusting and cleaning the bed before sleeping; sleep position; turning off light before sleep; cover mouth when yawning and reciting some verses such as Ayat Kursi, Al-Ikhlas, Al-Falq and An-Nas); 3) providing mp3 and prayers beads to facilitate Qur'an recitation and zikr. These surat was chosen because the portion of surat concentrate on the absolute divinity of Allah and Allah's blessings to His creatures. The surat brings every Muslim the closeness to Allah, the calmness of the soul, and the cure for many physical and psychological diseases. The steps in sunnah of sleeping can be performed approximately about 10-15 minutes about 30 minutes prior to sleep.
| Study group | Role | What they receive |
|---|---|---|
| Education on sunnah of sleeping | Experimental | Participants in the experimental group received education on sunnah of sleeping for two weeks. The interventions had three session which conducted between 40-60 minutes per session. The session include: 1) introducing the research objectives, definition and benefits on sunnah of sleeping; 2) steps in sunnah of sleeping 3) providing mp3 and prayers beads to facilitate Qur'an recitation and zikr. These surat was chosen because the portion of surat concentrate on the absolute divinity of Allah and Allah's blessings to His creatures. The steps in sunnah of sleeping can be performed approximately about 10-15 minutes about 30 minutes prior to sleep. Receives: Behavioral: Education on sunnah of sleeping |
| Control group | No intervention | While the experiment group received education on sunnah of sleeping, the control group received standard care without receiving the education on sunnah of sleeping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) has 19 items to assess sleep quality which can be categorized to seven domain; (1) sleep quality; (2) sleep latency; (3) sleep duration; (4) habitual sleep efficiency; (5) sleep disturbance; (6) sleep medication and (7) daytime sleep disturbance. The total score 1-21, where a higher total score reflect lower sleep quality.
Measured: Will be measured at base line and after three weeks, prior to hemodialysis procedure
Fatigue
The FSS was used to assess participant's fatigue and its impact to activities and life style. The FSS has nine items, with response options from 1-7, where a higher total score reflects higher fatigue
Measured: Will be measured at base line and after three weeks, prior to hemodialysis procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 May 2024
- Primary completion31 Aug 2024
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Yogyakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erna Rochmawati, Universitas Muhammadiyah Yogyakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642194
- Sponsor's protocol ID
- Sunnah on sleeping
- Acronym
- sleeping
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and
- ClinicalTrials.gov ID
- NCT06642194
- Acronym / sponsor ID
- sleeping / Sunnah on sleeping
- Conditions
- Sleep Quality, Fatigue, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah YogyakartaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education on sunnah of sleeping | Experimental | Behavioral: Education on sunnah of sleepingParticipants in the experimental group received education on sunnah of sleeping for two weeks. The interventions had three session which conducted between 40-60 minutes per session. The session include: 1) introducing the research objectives, definition and benefits on sunnah of sleeping; 2) steps in sunnah of sleeping 3) providing mp3 and prayers beads to facilitate Qur'an recitation and zikr. These surat was chosen because the portion of surat concentrate on the absolute divinity of Allah and Allah's blessings to His creatures. The steps in sunnah of sleeping can be performed approximately about 10-15 minutes about 30 minutes prior to sleep. |
| Control group | No intervention | –While the experiment group received education on sunnah of sleeping, the control group received standard care without receiving the education on sunnah of sleeping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants were excluded if they had unstable vital signs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on sunnah of sleepingThe interventions had three session which conducted between 40-60 minutes per session. The session include: 1) introducing the research objectives, definition and benefits on sunnah of sleeping; 2) steps in sunnah of sleeping (early bedtime and early wake up time; perform ablution (wudoo) before going to bed and supplicate; dusting and cleaning the bed before sleeping; sleep position; turning off light before sleep; cover mouth when yawning and reciting some verses such as Ayat Kursi, Al-Ikhlas, Al-Falq and An-Nas); 3) providing mp3 and prayers beads to facilitate Qur'an recitation and zikr. These surat was chosen because the portion of surat concentrate on the absolute divinity of Allah and Allah's blessings to His creatures. The surat brings every Muslim the closeness to Allah, the calmness of the soul, and the cure for many physical and psychological diseases. The steps in sunnah of sleeping can be performed approximately about 10-15 minutes about 30 minutes prior to sleep. | Behavioural | Education on sunnah of sleeping |
Primary outcome
Sleep quality
Time frame: Will be measured at base line and after three weeks, prior to hemodialysis procedure
The Pittsburgh Sleep Quality Index (PSQI) has 19 items to assess sleep quality which can be categorized to seven domain; (1) sleep quality; (2) sleep latency; (3) sleep duration; (4) habitual sleep efficiency; (5) sleep disturbance; (6) sleep medication and (7) daytime sleep disturbance. The total score 1-21, where a higher total score reflect lower sleep quality.
Fatigue
Time frame: Will be measured at base line and after three weeks, prior to hemodialysis procedure
The FSS was used to assess participant's fatigue and its impact to activities and life style. The FSS has nine items, with response options from 1-7, where a higher total score reflects higher fatigue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided. The study will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on sunnah of sleeping in people with Sleep Quality and Fatigue, run by Universitas Muhammadiyah Yogyakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Will be measured at base line and after three weeks, prior to hemodialysis procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.