The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients

NCT ID: NCT06263764

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-07-31

Brief Summary

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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

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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

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Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Qur'an Arm

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.

Group Type EXPERIMENTAL

Listening to Qur'an Recital

Intervention Type OTHER

Listening to Surah Ar Rahman twice a day for minimum 15 minutes each for 40 days

Control Arm

The control group will not receive any specific intervention and will continue with their usual routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Listening to Qur'an Recital

Listening to Surah Ar Rahman twice a day for minimum 15 minutes each for 40 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,

Exclusion Criteria

* Cannot read or write,
* Using drugs that affect the work of the central nervous system,
* Not willing to take part in research.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dr. dr. Alvina Widhani, Sp.PD, KAI

Staff of Allergy Immunology Division, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rudi Putranto, PhD

Role: STUDY_DIRECTOR

Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Sukamto Koesnoe, PhD

Role: STUDY_DIRECTOR

Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Alvina Widhani, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Karina Wijayanti, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Locations

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Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Alvina Widhani, PhD

Role: CONTACT

+6281905910034

Karina Wijayanti, MD

Role: CONTACT

085226207270

Facility Contacts

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Alvina Widhani, PhD

Role: primary

+6281905910034

Karina Wijayanti, MD

Role: backup

+6285226207270

References

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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.

Reference Type BACKGROUND
PMID: 28900859 (View on PubMed)

Other Identifiers

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23-11-1954

Identifier Type: -

Identifier Source: org_study_id

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