- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893770
The Effect of the Quran on Quality of Life and Quality of Sleep in Breast Cancer
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: DERYA ŞİMŞEKLİ
- Phone Number: +9005545965789
- Email: deryasimsekli95@gmail.com
Study Contact Backup
- Name: Bedriye Cansu KOYUNOĞLU
- Phone Number: +9005379652960
- Email: bedriye.koyunoglu@erzurum.edu.tr
Study Locations
-
-
-
Erzurum, Turkey, 252500
- Erzurum Technical Universitesi
-
Contact:
- DERYA ŞİMŞEKLİ
- Phone Number: +9005545965789
- Email: deryasimsekli95@gmail.com
-
Contact:
- BEDRİYE CANSU KOYUNOĞLU
- Email: bedriye.koyunoglu@erzurum.edu.tr
-
Contact:
- KOYUNOĞLU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
|
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: DERYA ŞİMŞEKLİ, Ardahan University
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
- ArdahanU-Simsekli-DS-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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