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临床试验/NCT06263764
NCT06263764招募中不适用

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

Indonesia University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Difference in Quality of Life Pre and Post Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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,

排除标准

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

研究组 & 干预措施

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.

干预措施: Listening to Qur'an Recital (Other)

Control Arm

No Intervention

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

结局指标

主要结局

Difference in Quality of Life Pre and Post Intervention

时间窗: 40 days

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

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

Indonesia University

研究点 (2)

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