Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children

May 16, 2026 updated by: SEDA ARDAHAN SEVGİLİ, Ege University

The Effect of Music Recital and Virtual Reality on Pain, Anxiety and Fear During Oral Mucositis Care in Children With Leukaemia: A Randomised Controlled Study

Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The participant child

  • is between the ages of 6-12 years
  • is being followed up as an inpatient in the Paediatric Haematology Clinic
  • is receiving leukaemia treatment only
  • has oral mucositis
  • does not have a systemic infection
  • willing to participate in the study
  • speak Turkish and are open to communication
  • has no visual and hearing problems (not using glasses or hearing aids)

Exclusion Criteria:

  • Cases not fulfilling the inclusion criteria will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group1
Active Comparator: Group2
Relaxing Music Session
Procedure: Music intervention
The music for the study will be the 'MusiCure® 9 Scandinavia' compositions specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) (MusiCure, 2024). The compositions include melodies with harp, cello, strings and sounds from nature (birds, forest and night sounds) in a soft rhythm between 60-80 bpm for relaxation, based on research into the acoustic environment of hospitals and shown to have a positive effect on patients' symptoms such as pain, fear and anxiety. Two minutes after the child starts listening to the music, oral mucositis care will be started. Five minutes after the end of the procedure, the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale will be applied and the duration of the procedure will be recorded.
Active Comparator: Group3
Short Film Session via VR (Relaxing Nature)
Procedure: Virtual reality
In this group, children will be shown a short film with virtual reality glasses. In the study, the short film 'MusiCure® The Journey' specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) will be preferred in the virtual reality group. The duration of the film is 16 minutes (MusiCure, 2024). Two minutes after the child starts watching the film, oral mucositis care will be started. Five minutes after the end of the procedure, the duration of the procedure will be recorded by applying the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedural pain
Time Frame: Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.
The difference in pain score in different groups will be recorded.
Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.
anxiety
Time Frame: Five minutes before starting the mucositis care procedure, the child's anxiety will be measured and baseline data will be collected. Anxiety data will be collected again immediately after the mucositis care procedure is completed.
The difference in anxiety score in different groups will be recorded.
Five minutes before starting the mucositis care procedure, the child's anxiety will be measured and baseline data will be collected. Anxiety data will be collected again immediately after the mucositis care procedure is completed.
fear
Time Frame: Five minutes before starting the mucositis care procedure, the child's fear will be measured and baseline fear data will be collected. Fear data will be collected again immediately after the mucositis care procedure is completed.
The difference in fear score in different groups will be recorded.
Five minutes before starting the mucositis care procedure, the child's fear will be measured and baseline fear data will be collected. Fear data will be collected again immediately after the mucositis care procedure is completed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of crying
Time Frame: After the procedure is explained to fam/child, the duration of crying will be recorded in all groups during the mucositis intervention. The recording will last till the last moment when the equipment used for care is removed from the mouth
The study will record the differences in crying times of children in different groups.
After the procedure is explained to fam/child, the duration of crying will be recorded in all groups during the mucositis intervention. The recording will last till the last moment when the equipment used for care is removed from the mouth
duration of oral mucositis care
Time Frame: After the procedure is explained to fam/child, the duration of procedure will be recorded in all groups. The recording will last till the last moment when the equipment used for care is removed from the mouth
The difference in processing time in different groups will be recorded.
After the procedure is explained to fam/child, the duration of procedure will be recorded in all groups. The recording will last till the last moment when the equipment used for care is removed from the mouth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.03.2025/2100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will not be shared for ethical reasons.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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