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

February 8, 2024 updated by: Dr. dr. Alvina Widhani, Sp.PD, KAI, Indonesia University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Listening to Qur'an Recital
Listening to Surah Ar Rahman twice a day for minimum 15 minutes each for 40 days
No Intervention: Control Arm
The control group will not receive any specific intervention and will continue with their usual routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Quality of Life Pre and Post Intervention
Time Frame: 40 days
Difference in quality of life score (Lupus-QoL score)
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Study Director: Rudi Putranto, PhD, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
  • Study Director: Sukamto Koesnoe, PhD, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
  • Principal Investigator: Alvina Widhani, PhD, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia
  • Principal Investigator: Karina Wijayanti, MD, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-11-1954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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