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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings