Quality of LifeNCT06263764
The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients
A study testing Listening to Qur'an Recital in people with Quality of Life, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Listening to Qur'an Recital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Feb 2024to 31 Jul 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemic Lupus Erythematosus Patients based on EULAR/ACR 2019 diagnostic criteria,
- Female aged ≥ 18 years old,
- Muslim (follower of the religion of Islam),
- Have no auditory problems,
- Received a steroid dose ≤ 20 mg/day equivalent to prednisone,
Who cannot join
- Cannot read or write,
- Using drugs that affect the work of the central nervous system,
- Not willing to take part in research.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Jakarta, 10430
Alvina Widhani, PhD, +6281905910034, alvina.widhani@gmail.com
Karina Wijayanti, MD, +6285226207270, karinawija@gmail.com
About this study
The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life.
Read the detailed description
Subjects who meet the eligibility criteria will be classified into intervention and control groups based on their Qur'an listening routine. Those who listen to the Qur'an less than once a week will be included in the control group. On the other hand, those who listen to the Qur'an once or more a week will be included in the intervention group. Before the intervention, we will also evaluate the potential confounding factors in each respondent that could affect quality of life, such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety or depression, comorbidities, and economic status.
Subjects in the intervention group will be asked to listen to the Al Qur'an recital (QS. Ar-Rahman) with a minimum duration of 15 minutes each, twice every day for 40 days, through an MP3 player using a headset or earphone. They will listen to the same Qur'an recital that is recited by Freed Ghalib. To ensure the respondents listen to the Qur'an recital Surah Ar-Rahman, the researcher will call and message via the Whats App application to research subjects every day for reminding. Respondents are also given a checklist card that will be filled out each time they are finished listening to the Qur'an recital. The control group will be asked not to change their habits of listening to or reading the Qur'an during this period. In addition, both the intervention and control groups will also be asked to inform the researchers if they read the Qur'an during the intervention or monitoring period.
- Conditions
- Quality of Life
- Being tested
- Listening to Qur'an Recital
- Keywords
- Quran Recital, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to Qur'an RecitalOther
Listening to Surah Ar Rahman twice a day for minimum 15 minutes each for 40 days
| Study group | Role | What they receive |
|---|---|---|
| Qur'an Arm | Experimental | Participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days.
The participants will listen to the same Qur'an recital (recited by Freed Ghalib) using the same MP3 player. Receives: Other: Listening to Qur'an Recital |
| Control Arm | No intervention | The control group will not receive any specific intervention and will continue with their usual routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Quality of Life Pre and Post Intervention
Difference in quality of life score (Lupus-QoL score)
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start12 Feb 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Alvina Widhani, Sp.PD, KAI, Universitas Indonesia
- Investigators
- Rudi Putranto, PhD, Study director, Department of Internal Medicine, Faculty of Medicine Universitas IndonesiaSukamto Koesnoe, PhD, Study director, Department of Internal Medicine, Faculty of Medicine Universitas IndonesiaAlvina Widhani, PhD, Principal investigator, Department of Internal Medicine, Faculty of Medicine Universitas IndonesiaKarina Wijayanti, MD, Principal investigator, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263764
- Sponsor's protocol ID
- 23-11-1954
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z.
PubMed 28900859
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06263764
- Acronym / sponsor ID
- 23-11-1954
- Conditions
- Quality of Life
- Keywords
- Quran Recital, Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Feb 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.
The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life.
Detailed description
Subjects who meet the eligibility criteria will be classified into intervention and control groups based on their Qur'an listening routine. Those who listen to the Qur'an less than once a week will be included in the control group. On the other hand, those who listen to the Qur'an once or more a week will be included in the intervention group. Before the intervention, we will also evaluate the potential confounding factors in each respondent that could affect quality of life, such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety or depression, comorbidities, and economic status.
Subjects in the intervention group will be asked to listen to the Al Qur'an recital (QS. Ar-Rahman) with a minimum duration of 15 minutes each, twice every day for 40 days, through an MP3 player using a headset or earphone. They will listen to the same Qur'an recital that is recited by Freed Ghalib. To ensure the respondents listen to the Qur'an recital Surah Ar-Rahman, the researcher will call and message via the Whats App application to research subjects every day for reminding. Respondents are also given a checklist card that will be filled out each time they are finished listening to the Qur'an recital. The control group will be asked not to change their habits of listening to or reading the Qur'an during this period. In addition, both the intervention and control groups will also be asked to inform the researchers if they read the Qur'an during the intervention or monitoring period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qur'an Arm | Experimental | Other: Listening to Qur'an RecitalParticipants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The participants will listen to the same Qur'an recital (recited by Freed Ghalib) using the same MP3 player. |
| Control Arm | No intervention | –The control group will not receive any specific intervention and will continue with their usual routine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemic Lupus Erythematosus Patients based on EULAR/ACR 2019 diagnostic criteria,
- Female aged ≥ 18 years old,
- Muslim (follower of the religion of Islam),
- Have no auditory problems,
- Received a steroid dose ≤ 20 mg/day equivalent to prednisone,
Key exclusion criteria (3 listed)
- Cannot read or write,
- Using drugs that affect the work of the central nervous system,
- Not willing to take part in research.
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 |
|---|---|---|
| Listening to Qur'an RecitalListening to Surah Ar Rahman twice a day for minimum 15 minutes each for 40 days | Other | Qur'an Arm |
Primary outcome
Difference in Quality of Life Pre and Post Intervention
Time frame: 40 days
Difference in quality of life score (Lupus-QoL score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 28900859Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z.
- Individual participant dataSharing planned: No
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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.
Rudi Putranto, PhD study director
Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
Sukamto Koesnoe, PhD study director
Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
Alvina Widhani, PhD principal investigator
Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to Qur'an Recital in people with Quality of Life, run by Universitas Indonesia 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 5 inclusion and 3 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 16 Feb 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?
Contact Alvina Widhani, PhD (+6281905910034, alvina.widhani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Quality of Life Pre and Post Intervention (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263764, which also lists 1 linked publication.
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 16 Feb 2024.