NCT07621861

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 29, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 28, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Participants will listen to calming music for 20 minutes before bedtime each night during chemotherapy.

Music Group

Participants will listen to Holy Qur'an recitation for 20 minutes before bedtime each night during chemotherapy.

Holy Qur'an Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiwa Cancer Hospital

Erbil, Kurdistan Region, Iraq

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Degree Student, College of Nursing

Study Record Dates

First Submitted

April 28, 2026

First Posted

June 2, 2026

Study Start

October 29, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations