The Effect of the Quran on Quality of Life and Quality of Sleep in Breast Cancer

March 18, 2025 updated by: Ardahan University

Effect of Quran Recital on Quality of Life and Quality of Sleep in Patients Receiving Chemotherapy Due to Breast Cancer

Objective: This study aims to investigate the effects of Quran on quality of life and sleep in patients receiving chemotherapy due to breast cancer.

Method: This study will be conducted with 40 patients with breast cancer receiving chemotherapy at Erzurum City Hospital Outpatient Chemotherapy Unit in a randomized controlled experimental design. Block randomization will be used in group assignment. The breast cancer patient identification form, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30) and Pittsburg Sleep Quality Index (PSQI) will be used to collect research data. It is planned to collect research data with a total of four measurements during the application of the first, second, third and last protocols of chemotherapy.

Expected Results: As a result of the study, it is expected that Quran recitation will have a positive effect on quality of life and sleep in patients receiving chemotherapy due to breast cancer.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

40

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

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:

  • Having breast cancer
  • Being on chemotherapy
  • Being on a chemotherapy protocol every 21 days
  • Being over the age of 18
  • Not having communication problems
  • Being willing to participate in the study

Exclusion Criteria:

  • Having a hearing problem
  • Having an ear infection or any condition that prevents hearing
  • Having other types of cancer other than breast cancer

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Quran recital
standard treatment and care
Other Names:
  • standard treatment and care
Active Comparator: control group
standard treatment and care
standard treatment and care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30), Version 3.0 (EORTC QLQ C-30)
Time Frame: From registration to the end of treatment at week 12
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30), Version 3.0 (EORTC QLQ C-30) will be used to assess quality of life. High general well-being and functional subscale scores indicate high quality of life.
From registration to the end of treatment at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg Sleep Quality Index
Time Frame: From registration to the end of treatment at week 12
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. A score of six or above indicates poor sleep quality.
From registration to the end of treatment at week 12

Collaborators and Investigators

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

Investigators

  • Principal Investigator: DERYA ŞİMŞEKLİ, Ardahan University

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)

April 15, 2025

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ArdahanU-Simsekli-DS-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data cannot be shared with third parties in order to protect personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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