Clinical trial NCT06955338: Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Fear
Keywords: leukemia
mucositis
fear
anxiety
pain
children
nursing
symptom management
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: procedural pain
timeFrame: 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.
measure: anxiety
timeFrame: 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.
measure: fear
timeFrame: 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 outcomes:
measure: duration of crying
timeFrame: 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
measure: duration of oral mucositis care
timeFrame: 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
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References: