The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs

NCT06479967 | Completed

• 1 other identifier: EU13021985
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Anxiety; Pain; Itching; Vital Signs

Keywords

allergy; skin test; children; itching; musictherapy; Pain; Anxiety; Virtual 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 group OTHER

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 group OTHER

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

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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.

Sponsors & Collaborators

• Uludag University: lead

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: 34036696 BACKGROUND

• 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: 33964406 BACKGROUND

• 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: 31838780 BACKGROUND

• 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: 24943088 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity; Anxiety Disorders; Pain; Pruritus

Condition Hierarchy (Ancestors)

Immune System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin 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

Locations

TU (1)