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Completed

NCT Number: NCT06479967

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

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.

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Key information

Conditions

Allergy Anxiety Anxiety Disorders Hypersensitivity Immune System Diseases Itching Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Vital Signs

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uludag Üniversty

Bursa, 19600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Anxiety level

    Time frame: 12 week

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

  2. Pain Levels

    Time frame: 12 week

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

  3. 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

  4. 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.

  5. Oxygen Saturation

    Time frame: 12 week

    Oxygen Saturation. ( between % 95-100)

  6. Respiratory Rate

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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