Efficacy of an Integrated Psychological Interventions Combined With Ar_Rahman Listening for Reducing Psychological Distress and Enhancing Hope and Quality of Life Among Cancer Patients: A Randomized Controlled Trial
This is a randomized control trial(RCT ID:25142101) to evaluate the efficacy of psychological intervention combined with listening to surah Ar- RAhman for reducing psychological distress and improving cancer patients' hope and overall QOL compare to standard care. participants will be randomly assigned to two groups: intervention group will receive 14-sessions based manualized psychotherapy plus daily listening to surah Ar- rehman for 12 weeks, and control group will receive standard care .psychological distress will be measured with DASS-21, Quality of Life (QLQ-C30) for assessing Quality of life and Adult hope scale for assessing hope before and after the intervention.
Study Overview
Status
Intervention / Treatment
Detailed Description
this is a two- arm parallel randomized control trial. Background: psychological distress is common in cancer patients and affects treatment outcomes. spiritual and religious interventions, particularly, listening to QURAN recitation(Surah Ar Rahman), have shown potential to reduce anxiety and depression giving hope anf improving overall QOL.
objective: To determine the effectiveness of psychological intervention combined with Surah Ar Rahman listening in reducing psychological distress and enhancing hope and Quality of Life in cancer patients Methods: approximately 60 adults cancer patients will be recruited and randomized(1:1) into intervention and control groups. intervention group: 8 weekly psychological counseling session (30-45 min) based on supportive psychotherapy and CBT techniques plus listening to surah Ar Rahman recitation by Qari Abdul Basit (20 min daily). control group : Standard medical care and general information. assessment at pre and post intervention .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mobeen mehmood, PhD
- Phone Number: 03709191770
- Email: mobeen1770@gmail.com
Study Locations
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Islamabad, Pakistan, 44000
- Oncology department, IMPS, Noori & Shia International Hospital
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Contact:
- mobeen mehmood
- Phone Number: 03709191770
- Email: mobeen1770@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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Inclusion Criteria
- Aged 18 years or older
- Have a confirmed diagnosis of cancer stage I and II will be included to obtain a relatively comparable clinical population and reduce variability associated with advanced disease and palliative care needs.
- Are currently receiving or have received cancer-related treatment, such as chemotherapy, radiotherapy, surgery, immunotherapy, or other oncological treatment.
- Education level will be matric atleast
- Muslim patients
- Able to communicate and provide consent
Exclusion Criteria:
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• Severe psychiatric disorders
- Cognitive impairment
- Hearing impairments preventing audio participation
- Physically unfit for this study's interventions (for example who are bed-bonded or too weak to engage in the study interventions)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
participants will receive 12 week of psychological intervention weekly(30-45 min) counseling based supportive therapy plus daily listening to surh Ar Rahman recitation (Qari abdul basit, 20 min) via audio player. |
participants in experimental group will receive 12 week psychological intervention : weekly 30-45 min counseling based on supportive therapy plus daily listening to Surah Ar Rahman recitation ( Qari Abdul Basit , 20 min ) via audio player, participants will be provided audio and intructed to listen daily and maintain a log. |
|
No Intervention: control group
participants will receive standard oncological care and general health information without psychological intervention or QURAN recitation |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
psychological distress (DASS-21)
Time Frame: baseline and 12 weeks post intervention
|
Psychological distress will be measured using DASS-21, a 21 item self-report instrument with 3 subscales: Depression (7 items) Anxiety(7 items) and stress(7 items). each item is scored on 0-3 Likert scale. total score range is 0-63, Scores of each subscale are categorized into five severity ranges: Normal, mild, moderate, severe and extremely severe. For depression normal range(0-9), mild(10-13), Moderate(14-20), Severe(21-27), Extremely severe(28+), for anxiety normal range(0-7), mild(8-9), Moderate(10-14), Severe(15-19), Extremely severe(20+),for stress normal range(0-14), mild(15-18), Moderate(19-25), Severe(26-33), Extremely severe(34+) While the scores do not provide a functional diagnosis, they indicate the potential presence of depression, anxiety, and stress |
baseline and 12 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life -EORTC QLQ-C30
Time Frame: Baseline and 12 week post-intervention
|
Quality of life will be measured using European Organization for Research and treatment of Cancer Quality of life Questionnaire(EORTC-QLQ-C30) Version 3.0. it is 30-item questionnaire composed of 5 functional scales, 3 symptoms scales, a global health status scale and 6 single items. scores are transformed to 0-100 scale. higher score in functioning and global QoL indicates better QOL, higher score in symptoms indicates worse symptoms |
Baseline and 12 week post-intervention
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Adult Hope scale(AHS)
Time Frame: baseline and 12 weeks post intervention
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hope will be measured using Adult hope scale(Snyder et al.,1991). it is 12-items scale with 4 agency items , 4 pathways items, and 4 distractors. items are scored on an 8-point Likert scale from 1- definitely False to 8= definitely true. total score range is 8-64. excluding distractors. higher score indicates higher level of hope |
baseline and 12 weeks post intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZABIST-ISB-25142101-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
individual participants data(IPD) will not be shared due to ethical restrictions and to protect patient confidentiality as per institutional review board(IRB) policy. the study involved sensitive psychological data of cancer patients. De-identified summary data maybe available from principal investigator upon reasonable request after publication.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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