NCT06893770

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 10, 2025

Last Update Submit

March 18, 2025

Conditions

Breast Carcinoma

Keywords

breast cancerQuran recitallife of qualitysleep of quality

Outcome Measures

Primary Outcomes (1)

  • The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30), Version 3.0 (EORTC QLQ C-30)

    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 Outcomes (1)

  • Pittsburg Sleep Quality Index

    From registration to the end of treatment at week 12

Study Arms (2)

experimental group

EXPERIMENTAL

Quran recital

Behavioral: Quran recital

control group

ACTIVE COMPARATOR

standard treatment and care

Other: standard treatment and care

Interventions

Quran recitalBEHAVIORAL

standard treatment and care

Also known as: standard treatment and care
experimental group
standard treatment and careOTHER

standard treatment and care

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical Universitesi

Erzurum, Turkey, 252500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • DERYA ŞİMŞEKLİ

    Ardahan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya ŞİMŞEKLİ

CONTACT

+9005545965789deryasimsekli95@gmail.com

Bedriye Cansu KOYUNOĞLU

CONTACT

+9005379652960bedriye.koyunoglu@erzurum.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Before the study, a separate consent form was prepared for the experimental group and a separate consent form for the control group, and it was planned to blind the participants by not informing them about which group they were in. In addition, data will be entered with group 1 and group 2 coding for the Quran recital group and the control group, and it was planned to apply statistician blinding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 25, 2025

Study Start

April 15, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)