The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children

NCT06421779 | Completed

• 1 other identifier: ADUPIA-CSAHIN-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR.

Conditions

Pain; Fear; Fear of Pain; Child, Only; Allergy

Keywords

Skin Prick Test; Virtual Reality; Pain; Fear; Child; Allergy

Outcome Measures

Primary Outcomes (2)

• Skin prick test-related pain

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 10 from left to right (0 = very happy face/no pain, 10 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?".

  Through painful procedure completion, an average of 10 minutes.

• Skin prick test-related fear

  The Child Fear Scale (CFS) used. The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4.

  Through fearful procedure completion, an average of 10 minutes.

Study Arms (2)

Experimental: VR

EXPERIMENTAL

Children in the VR group put on VR glasses for approximately two minutes before the skin prick test and watched a VR underwater experience video throughout the procedure.

Behavioral: Virtual reality (VR)

No Intervention: Control

NO INTERVENTION

Children in the control group underwent a routine skin prick test procedure. Control group children did not receive any distraction techniques.

Interventions

Virtual reality (VR) BEHAVIORAL

Children watch underwater experience video by wearing the virtual reality glass during the skin prick test.

Experimental: VR

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• being between the ages of 4-10 years
• requirement of skin prick test due to allergic diseases

You may not qualify if:

• having chronic diseases (except allergic diseases)
• vision, hearing, and speech disorders
• psychiatric and neurological diseases
• mental status disorder, learning and perception disorder
• a history of pre-procedure sedative, analgesic or narcotic drug use within 24 hours
• a history of active infection
• those who are scheduled to undergo a skin test other than an aeroallergen panel
• contra-indicated conditions for skin prick testing such as dermographism, severe eczema, being under drugs (immunosuppressive drugs, antihistamine, steroid, etc)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University, School of Medicine, Department of Pediatric Immunology and Allergy

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

• Sahin C, Cinakli S, Atar Bese S, Tuncerler G, Torer N, Erge D, Uysal P. The effect of virtual reality on skin prick test-related pain and fear in children: a randomized controlled trial. Eur J Pediatr. 2025 Jun 18;184(7):427. doi: 10.1007/s00431-025-06262-x.

  PMID: 40528065 DERIVED

MeSH Terms

Conditions

Pain; Hypersensitivity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Cihangir Sahin

  Aydin Adnan Menderes University, Department of Pediatric Immunology and Allergy, Aydin, Türkiye

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Children aged 4 to 10 years for whom a skin prick test has been decided.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Medical Doctor

Model Details: A Prospective parallel group randomized controlled trial.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: March 22, 2024
• Primary Completion: June 24, 2024
• Study Completion: July 22, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)