Breast CarcinomaNCT06893770
The Effect of Quran Recitation on Quality of Life and Sleep Quality in Patients With Breast Cancer Receiving Chemotherapy
A study testing Quran recital and standard treatment and care in people with Breast Carcinoma, run by Ardahan University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effect of listening to Qur'an on quality of life and sleep quality in women undergoing chemotherapy for breast cancer. This single-blind randomized controlled trial included 40 women receiving chemotherapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Quran recital and standard treatment and care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a hearing problem
- Having an ear infection or any condition that prevents hearing
- Having other types of cancer other than breast cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Technical Universitesi
Erzurum, Turkey, 252500
About this study
To investigate the effect of listening to Qur'an on quality of life and sleep quality in women undergoing chemotherapy for breast cancer. This single-blind randomized controlled trial included 40 women receiving chemotherapy for breast cancer. Participants were assigned using block randomization to either a Qur'an listening group (QLG) or a control group (CG). The QLG listened to Qur'an recitation during chemotherapy sessions, while the CG received standard care only. Data were collected at four time points (T1-T4) using a patient information form, the EORTC QLQ-C30, and the Pittsburgh Sleep Quality Index (PSQI). Analyses were performed using SPSS 26. Across four measurements, the QLG showed significant improvements in all functional domains of the EORTC QLQ-C30 and significant reductions in most symptom domains (p < .05). No comparable changes were observed in the CG. Overall quality of life increased progressively from T1 to T4 in the QLG, with significant between-group differences emerging at T3 and T4. PSQI total scores decreased significantly in the QLG at T3 and T4 (p < .001), whereas no clinically meaningful improvement occurred in the CG. At T4, PSQI scores were significantly lower in the QLG than in the CG (p < .001). Listening to the Qur'an during chemotherapy significantly improves quality of life and sleep quality in women with breast cancer. This non-invasive, low-cost intervention may be integrated into supportive nursing care in oncology settings in accordance with patients' preferences.
- Conditions
- Breast Carcinoma
- Being tested
- Quran recital, standard treatment and care
- Keywords
- breast cancer, Quran recital, life of quality, sleep of quality
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quran recitalBehavioural
Also called standard treatment and care
standard treatment and care
standard treatment and careOther
standard treatment and care
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Quran listening Receives: Behavioral: Quran recital |
| control group | Active comparator | standard treatment and care Receives: Other: standard treatment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0, will be used to assess quality of life. The first 28 items are scored from 1 (not at all) to 4 (very much), while items 29 and 30 are scored from 1 (very poor) to 7 (excellent). Higher scores on the functional scales and Global Health Status/Quality of Life scale indicate better functioning and quality of life, whereas higher scores on the symptom scales and single-item measures indicate greater symptom burden.
Measured: From registration to the end of treatment at Week 12, with four measurements conducted during the first, second, third, and final chemotherapy protocols.
Secondary outcomes (1)
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The scale consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3. The total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 indicates poor sleep quality.
Measured: From registration to the end of treatment at Week 12, with four measurements conducted during the first, second, third, and final chemotherapy protocols.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Apr 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum Technical University
- Responsible party
- Principal investigator, Derya Şimşekli, Ardahan University
- Investigators
- DERYA ŞİMŞEKLİ, Principal investigator, Ardahan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893770
- Sponsor's protocol ID
- ArdahanU-Simsekli-DS-05
- Other IDs
- 2025/003
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared with third parties in order to protect personal data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quran Recitation on Quality of Life and Sleep Quality in Patients With Breast Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06893770
- Acronym / sponsor ID
- ArdahanU-Simsekli-DS-05
- Conditions
- Breast Carcinoma
- Keywords
- breast cancer, Quran recital, life of quality, sleep of quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Collaborators
- Erzurum Technical University
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of listening to Qur'an on quality of life and sleep quality in women undergoing chemotherapy for breast cancer. This single-blind randomized controlled trial included 40 women receiving chemotherapy for breast cancer. Participants were assigned using block randomization to either a Qur'an listening group (QLG) or a control group (CG). The QLG listened to Qur'an recitation during chemotherapy sessions, while the CG received standard care only. Data were collected at four time points (T1-T4) using a patient information form, the EORTC QLQ-C30, and the Pittsburgh Sleep Quality Index (PSQI). Analyses were performed using SPSS 26. Across four measurements, the QLG showed significant improvements in all functional domains of the EORTC QLQ-C30 and significant reductions in most symptom domains (p < .05). No comparable changes were observed in the CG. Overall quality of life increased progressively from T1 to T4 in the QLG, with significant between-group differences emerging at T3 and T4. PSQI total scores decreased significantly in the QLG at T3 and T4 (p < .001), whereas no clinically meaningful improvement occurred in the CG. At T4, PSQI scores were significantly lower in the QLG than in the CG (p < .001). Listening to the Qur'an during chemotherapy significantly improves quality of life and sleep quality in women with breast cancer. This non-invasive, low-cost intervention may be integrated into supportive nursing care in oncology settings in accordance with patients' preferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Quran recitalQuran listening |
| control group | Active comparator | Other: standard treatment and carestandard treatment and care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having breast cancer
- Being on chemotherapy
- Being on a chemotherapy protocol every 21 days
- Being over the age of 18
- Not having communication problems
Key exclusion criteria (3 listed)
- Having a hearing problem
- Having an ear infection or any condition that prevents hearing
- Having other types of cancer other than breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quran recitalAlso: standard treatment and carestandard treatment and care | Behavioural | experimental group |
| standard treatment and carestandard treatment and care | Other | control group |
Primary outcome
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0
Time frame: From registration to the end of treatment at Week 12, with four measurements conducted during the first, second, third, and final chemotherapy protocols.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0, will be used to assess quality of life. The first 28 items are scored from 1 (not at all) to 4 (very much), while items 29 and 30 are scored from 1 (very poor) to 7 (excellent). Higher scores on the functional scales and Global Health Status/Quality of Life scale indicate better functioning and quality of life, whereas higher scores on the symptom scales and single-item measures indicate greater symptom burden.
1 secondary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From registration to the end of treatment at Week 12, with four measurements conducted during the first, second, third, and final chemotherapy protocols.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared with third parties in order to protect personal data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DERYA ŞİMŞEKLİ principal investigator
Ardahan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quran recital and standard treatment and care in people with Breast Carcinoma, run by Ardahan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0 (time frame: From registration to the end of treatment at Week 12, with four measurements conducted during the first, second, third, and final chemotherapy protocols.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.