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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 .
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: mobeen mehmood, PhD
- Número de teléfono: 03709191770
- Correo electrónico: mobeen1770@gmail.com
Ubicaciones de estudio
-
-
-
Islamabad, Pakistán, 44000
- Oncology department, IMPS, Noori & Shia International Hospital
-
Contacto:
- mobeen mehmood
- Número de teléfono: 03709191770
- Correo electrónico: mobeen1770@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
-
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:
-
• 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
|
Sin intervención: control group
participants will receive standard oncological care and general health information without psychological intervention or QURAN recitation |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
psychological distress (DASS-21)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Life -EORTC QLQ-C30
Periodo de tiempo: 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
|
|
Adult Hope scale(AHS)
Periodo de tiempo: baseline and 12 weeks post intervention
|
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
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SZABIST-ISB-25142101-RCT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .