NCT06479967

Brief Summary

Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation. Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes. Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.

Trial Health

87
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
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 13, 2024

Last Update Submit

June 28, 2024

Conditions

AllergyAnxietyPainItchingVital Signs

Keywords

allergyskin testchildrenitchingmusictherapyPainAnxietyVirtual Reality

Outcome Measures

Primary Outcomes (6)

  • Anxiety level

    State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)

    12 week

  • Pain Levels

    Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10")

    12 week

  • Itching level

    Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10

    12 week

  • Heart Rate

    Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110.

    12 weeks

  • Oxygen Saturation

    Oxygen Saturation. ( between % 95-100)

    12 week

  • Respiratory Rate

    Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute

    12 weeks

Study Arms (3)

Virtual Reality

EXPERIMENTAL

The Virtual Reality glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon

Other: The VR glasses group

Music

EXPERIMENTAL

The music group listened to classical piano "The Best of Chopin." After the music group took a 1-minute break from listening to music, and the child's pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10.

Other: the music group

Control

NO INTERVENTION

Before, during, and after the skin prick test evaluation (15 minutes), no intervention was provided to the children assigned to the control group.

Interventions

The VR glasses groupOTHER

The Virtual Reality glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of \"Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon

Virtual Reality
the music groupOTHER

The music group listened to classical piano \"The Best of Chopin.\" After the music group took a 1-minute break from listening to music, and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10.

Music

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 9-12 undergoing their initial skin test
  • With no cognitive, visual, or auditory impairments
  • No recent medical encounters involving pain or anxiety within the past 3 months
  • Parents who volunteered for participation in this study.

You may not qualify if:

  • Those who are not between the ages of 9 and 12 and have had a skin prick test before
  • With cognitive, visual, or auditory impairments,
  • Recent medical encounters involving pain or anxiety within the past 3 months,
  • Parents who volunteered no for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag Üniversty

Bursa, 19600, Turkey (Türkiye)

Location

Related Publications (4)

  • Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.

    PMID: 34036696BACKGROUND

  • da Silva Santa IN, Schveitzer MC, Dos Santos MLBM, Ghelman R, Filho VO. MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102725. doi: 10.1016/j.ctim.2021.102725. Epub 2021 May 5.

    PMID: 33964406BACKGROUND

  • Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.

    PMID: 31838780BACKGROUND

  • Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.

    PMID: 24943088BACKGROUND

MeSH Terms

Conditions

HypersensitivityAnxiety DisordersPainPruritus

Condition Hierarchy (Ancestors)

Immune System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Study Officials

  • Eda UNAL, PhD

    Uludag universty

    PRINCIPAL INVESTIGATOR

  • Aysel OZDEMIR, PhD

    Uludag University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 28, 2024

Study Start

November 12, 2022

Primary Completion

June 15, 2023

Study Completion

December 15, 2023

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

No.

Locations

TU(1)