Holy Qur'an Versus Music Sound on Sleep Quality in Childr... | NCT07621861

Studies
Holy Qur'an Versus Music Sound on Sleep Quality in Children Undergoing Chemotherapy

NCT07621861

Sponsor

Rawand Shafeeq Ali

Status

Active, not recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Sleep Wake Disorders

Interventions

Music Therapy
Holy Qur'an Recitation

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2025Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Apr 28, 2026

First Submission Date that Met QC Criteria

Jun 1, 2026

First Posted Date

Jun 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rawand Shafeeq Ali, Master's Degree Student, College of Nursing, Hawler Medical UniversitySponsor-Investigator

Lead Sponsor

Rawand Shafeeq AliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized controlled trial aims to evaluate the effect of listening to Holy Qur'an recitation compared with music sound on sleep quality among children aged 6 to 10 years undergoing chemotherapy. Sleep disturbances are common in pediatric oncology patients and may negatively affect recovery, emotional well-being, and overall quality of life. Non-pharmacological interventions such as auditory therapy may help improve sleep without medication-related side effects.

Participants will be randomly assigned to either a Holy Qur'an listening group or a music sound listening group. Each intervention will be applied during bedtime over a specified period. Sleep quality will be assessed using the Children's Sleep Habits Questionnaire (CSHQ) and optional sleep diary data.

The study hypothesizes that children who listen to Holy Qur'an recitation will demonstrate greater improvement in sleep quality compared to those who listen to music sound. The findings may provide evidence for safe, culturally appropriate, and non-pharmacological interventions to enhance sleep quality in children undergoing chemotherapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Intervention: Control Group Receiving Routine Care	No Intervention	Participants in this group will receive routine hospital care during chemotherapy without any additional auditory intervention before sleep. No music or Holy Qur'an recitation will be provided.
Music Group	Experimental	using music sound 20 minute before bed time	Other: Music Therapy
Holy Qur'an Group	Experimental	using holly qurran sound 20 minute before bed time	Other: Holy Qur'an Recitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music Therapy	Other	Participants will listen to calming music for 20 minutes before bedtime each night during chemotherapy.	Music Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep Quality Score children sleep habit questionare (CSHQ-33 item)	The Children's Sleep Habits Questionnaire (CSHQ) is a 33-item parent-reported questionnaire assessing sleep behavior in children. Total scores range from 33 to 99, with higher scores indicating poorer sleep quality and more sleep disturbances.	Baseline and after 1 week of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children diagnosed with cancer and currently undergoing chemotherapy
Aged 6 to 10 years
Able to hear and respond to sound

Exclusion Criteria:

Children with hearing impairment
Children with known sleep disorder not related to chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiwa Cancer Hospital		Erbil	Kurdistan Region		Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Participants will be randomly assigned to one of three parallel groups: a control group receiving routine care, a Holy Qur'an recitation group, and a music sound group. All groups will be followed simultaneously during the study period. Participants will remain in their assigned group throughout the trial, and outcomes will be compared between the three groups to evaluate the effect of the interventions on sleep quality.

Masking Info

Masking

None (Open Label)

Masking Description

This study will use an open-label design with no masking. Participants, care providers, and investigators will be aware of group assignments because the interventions involve listening to different audio types (Holy Qur'an recitation, music sound, or routine care), which cannot be concealed. Outcome measures will be collected using standardized questionnaires to minimize potential bias.

Who Masked

Not provided