Clinical trial NCT06479967: The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs
Official title: The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Anxiety
Pain
Itching
Vital Signs
Keywords: allergy
skin test
children
itching
musictherapy
Pain
Anxiety
Virtual Reality
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 90
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Anxiety level
timeFrame: 12 week
measure: Pain Levels
timeFrame: 12 week
measure: Itching level
timeFrame: 12 week
measure: Heart Rate
timeFrame: 12 weeks
measure: Oxygen Saturation
timeFrame: 12 week
measure: Respiratory Rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag Üniversty
Study officials:
affiliation: Uludag universty
name: Eda UNAL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uludag University
name: Aysel OZDEMIR, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.