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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06479967
Enrollment
90
Registered
2024-06-28
Start date
2022-11-12
Completion date
2023-12-15
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Anxiety, Itching, Pain, Vital Signs

Keywords

allergy, skin test, children, itching, musictherapy, Pain, Anxiety, Virtual Reality

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.

Interventions

OTHERThe VR glasses group

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

OTHERthe music group

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.

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety level12 weekState-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)
Pain Levels12 weekWong-Baker Faces Pain Rating Scale (a score of 0 to excruciating pain a value of 10)
Itching level12 weekVisual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10
Heart Rate12 weeksHeart 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 Saturation12 weekOxygen Saturation. ( between % 95-100)
Respiratory Rate12 weeksRespiratory Rate ( one minute ) (/minute). Between 16-22 / minute

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026