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

Ege University

Status: Not yet enrolling

Conditions: Fear; Anxiety; Pain

Treatments: Procedure: Virtual reality; Procedure: Music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06955338

07.03.2025/2100

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group1

No Intervention group

Group2

Active Comparator group

Description:

Relaxing Music Session

Treatment:

Procedure: Music intervention

Group3

Active Comparator group

Description:

Short Film Session via VR (Relaxing Nature)

Treatment:

Procedure: Virtual reality