Virtual Reality Versus Game Card Distraction During Pediatric Wound Care

NCT07335666 | Completed

• 1 other identifier: VR-WOUNDCARE-04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This completed randomized study compared two distraction approaches with standard care during pediatric open wound care. Ninety children aged 5-10 years were assigned to standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality. Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were assessed immediately before and shortly after wound care. The purpose was to compare psychological and physiological responses among the three groups and to assess whether virtual reality provided additional benefit compared with game cards.

Conditions

Pediatric Wounds; Procedural Pain; Procedure-Related Anxiety; Procedural Fear

Keywords

Virtual Reality; Distraction Techniques; Game Card Distraction; Immersive Distraction; Pediatric Wound Care; Child-Centered Care; Non-Pharmacological Intervention; Procedural Pain Management; Procedural Anxiety

Outcome Measures

Primary Outcomes (3)

• Children's Fear Scale Score

  Fear was measured using the Children's Fear Scale. Scores range from 0 (no fear) to 4 (extreme fear), with higher scores indicating greater fear.

  Immediately before wound care and within 5 minutes after completion of wound care

• State-Trait Anxiety Inventory for Children-State Subscale Score

  State anxiety was measured using the State-Trait Anxiety Inventory for Children-State subscale. Scores range from 20 to 60, with higher scores indicating greater state anxiety.

  Immediately before wound care and within 5 minutes after completion of wound care

• Wong-Baker FACES Pain Rating Scale Score

  Pain intensity was measured using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain.

  Immediately before wound care and within 5 minutes after completion of wound care

Secondary Outcomes (2)

• Heart Rate

  Immediately before wound care and within 5 minutes after completion of wound care

• Peripheral Oxygen Saturation (SpO₂)

  Immediately before wound care and within 5 minutes after completion of wound care

Study Arms (3)

Standard Care Control Group

NO INTERVENTION

Participants received standard pediatric wound care according to institutional protocols, including wound cleansing, debridement, suturing when clinically indicated, and dressing, without a structured distraction intervention.

Distraction Game Card Group

EXPERIMENTAL

Participants received standard wound care plus distraction using laminated illustrated game cards with visual-search and pattern-recognition tasks. A trained researcher provided structured prompts throughout wound care.

Behavioral: Distraction Game Cards

Virtual Reality Distraction Group

EXPERIMENTAL

Participants received standard wound care plus passive immersive audiovisual virtual reality delivered using a smartphone-based headset throughout the procedure.

Behavioral: Virtual Reality Distraction

Interventions

Distraction Game Cards BEHAVIORAL

The distraction activity began immediately before wound care and continued throughout the procedure. A trained researcher used structured prompts approximately every 15-30 seconds to maintain engagement.

Distraction Game Card Group

Virtual Reality Distraction BEHAVIORAL

A smartphone-based VR BOX 3.0 headset displayed a preset sequence of age-appropriate 360-degree three-dimensional videos with background music and ambient sounds. No hand controllers, gaze-based selection, or other interactive controls were used. The intervention began immediately before wound care and continued throughout the procedure.

Virtual Reality Distraction Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5-10 years
• Presented with an open wound requiring cleansing, dressing, debridement, and/or suturing
• Hemodynamically stable at baseline, with peripheral oxygen saturation of at least 95 percentage and heart rate within age-appropriate limits
• Able to communicate sufficiently to complete the study assessments
• Written informed consent provided by a parent or legal guardian
• Verbal assent provided by the child

You may not qualify if:

• Neurodevelopmental or communication disorder that could interfere with study assessments
• Significant visual or hearing impairment
• Head or facial wound preventing use of the virtual reality headset
• History of motion sickness or a previous adverse reaction to virtual reality
• Receipt of sedatives or systemic opioid analgesics within 6 hours before the procedure
• Requirement for procedural sedation during wound care
• Any clinical condition judged by the attending physician to make participation inappropriate

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Ağrı Training and Research Hospital

Center, AĞRI, 04100, Turkey (Türkiye)

Location

Related Publications (5)

• Kaya M, Karaman Ozlu Z. The effect of virtual reality on pain, anxiety, and fear during burn dressing in children: A randomized controlled study. Burns. 2023 Jun;49(4):788-796. doi: 10.1016/j.burns.2022.06.001. Epub 2022 Jun 9.

  PMID: 35753857 BACKGROUND

• Olbrecht VA, O'Conor KT, Williams SE, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Pickerill HM, Ding L, Yang G, King CD. Transient Reductions in Postoperative Pain and Anxiety with the Use of Virtual Reality in Children. Pain Med. 2021 Nov 26;22(11):2426-2435. doi: 10.1093/pm/pnab209.

  PMID: 34175959 BACKGROUND

• Thybo KH, Friis SM, Aagaard G, Jensen CS, Dyekjaer CD, Jorgensen CH, Walther-Larsen S. A randomized controlled trial on virtual reality distraction during venous cannulation in young children. Acta Anaesthesiol Scand. 2022 Oct;66(9):1077-1082. doi: 10.1111/aas.14120. Epub 2022 Aug 11.

  PMID: 35898121 BACKGROUND

• Sanchez-Caballero E, Ortega-Donaire L, Sanz-Martos S. Immersive Virtual Reality for Pain and Anxiety Management Associated with Medical Procedures in Children and Adolescents: A Systematic Review. Children (Basel). 2024 Aug 13;11(8):975. doi: 10.3390/children11080975.

  PMID: 39201910 BACKGROUND

• Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.

  PMID: 35068011 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers were not masked. A separate research assistant who did not deliver the interventions and was not informed of group allocation administered the outcome measures and entered the data. Psychological outcomes were child self-reports, and participants were aware of the intervention they received.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a 1:1:1 ratio to three parallel groups: standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: April 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)