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Clinical Trials/NCT06479967
NCT06479967
Completed
Not Applicable

The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial

Uludag University1 site in 1 country90 target enrollmentNovember 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Allergy
Sponsor
Uludag University
Enrollment
90
Locations
1
Primary Endpoint
Respiratory Rate
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT 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. Key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.

Registry
clinicaltrials.gov
Start Date
November 12, 2022
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uludag University
Responsible Party
Principal Investigator
Principal Investigator

EDA UNAL

principal investigator

Uludag University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Respiratory Rate

Time Frame: 12 weeks

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

Pain Levels

Time Frame: 12 week

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

Anxiety level

Time Frame: 12 week

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

Itching level

Time Frame: 12 week

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

Heart Rate

Time Frame: 12 weeks

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.

Oxygen Saturation

Time Frame: 12 week

Oxygen Saturation. ( between % 95-100)

Study Sites (1)

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