NCT06263764

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 8, 2024

Last Update Submit

February 8, 2024

Conditions

Keywords

Quran RecitalSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Difference in Quality of Life Pre and Post Intervention

    Difference in quality of life score (Lupus-QoL score)

    40 days

Study Arms (2)

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.

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

Interventions

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

Qur'an Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jakarta, 10430, Indonesia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28900859BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvina Widhani, PhD

CONTACT

Karina Wijayanti, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff of Allergy Immunology Division, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

February 12, 2024

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations