Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care

NCT07335666 | Completed

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

Brief Summary

Children often experience fear, anxiety, and pain during wound care procedures, which can make treatment more difficult and distressing. Non-pharmacological distraction techniques may help reduce these negative experiences without the use of medications. Virtual reality (VR) provides immersive visual and auditory stimulation, while simple distraction tools such as game cards offer a low-cost alternative. This randomized controlled study aims to compare the effectiveness of immersive virtual reality glasses and distraction game cards in reducing fear, anxiety, pain, and physiological stress responses in children aged 5 to 10 years undergoing open wound care. Ninety children are randomly assigned to one of three groups: standard care alone, standard care with distraction game cards, or standard care with virtual reality glasses. Psychological outcomes (fear, anxiety, and pain) and physiological indicators (heart rate and oxygen saturation) are measured before and after the wound care procedure. The results of this study will help identify effective, non-pharmacological strategies to improve children's experiences during painful medical procedures and support child-centered care in pediatric clinical settings.

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; Pediatric Anxiety; Non-Pharmacological Intervention; Procedural Pain Management

Outcome Measures

Primary Outcomes (3)

• Procedural Fear

  Children's fear related to the wound care procedure, assessed using the Children's Fear Scale. Scores range from 0 (no fear) to 4 (extreme fear), with higher scores indicating greater fear.

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

• Procedural Anxiety

  Children's state anxiety during wound care, measured using the State Anxiety Inventory for Children. Total scores range from 20 to 60, with higher scores indicating greater anxiety.

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

• Procedural Pain Intensity

  Pain intensity experienced by children during wound care, assessed using the Wong-Baker Faces Pain Scale. Scores range from 0 (no pain) to 10 (worst possible pain).

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

Secondary Outcomes (2)

• Heart Rate

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

• Peripheral Oxygen Saturation (SpO₂)

  Immediately before the procedure 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 application, without any structured distraction intervention.

Distraction Game Card Group

EXPERIMENTAL

Participants received standard wound care combined with distraction using illustrated game cards. Children engaged in visual search and pattern recognition activities facilitated by a trained researcher throughout the wound care procedure.

Behavioral: Distraction Game Cards

Virtual Reality Distraction Group

EXPERIMENTAL

Participants received standard wound care combined with immersive virtual reality distraction delivered through virtual reality glasses displaying age-appropriate three-dimensional and 360-degree content during the procedure.

Behavioral: Virtual Reality Distraction

Interventions

Distraction Game Cards BEHAVIORAL

Laminated illustrated game cards containing visual search and pattern-recognition tasks were used as a behavioral distraction during pediatric wound care. A trained researcher facilitated engagement by asking structured questions approximately every 15-30 seconds throughout the procedure to maintain the child's attention.

Distraction Game Card Group

Virtual Reality Distraction BEHAVIORAL

Immersive virtual reality distraction was delivered using virtual reality glasses connected to a smartphone displaying age-appropriate three-dimensional and 360-degree audiovisual content throughout the wound care procedure to provide multisensory engagement and reduce procedural distress.

Virtual Reality Distraction Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Presentation with an open wound requiring wound care procedures such as cleansing, dressing, debridement, and/or suturing.
• Hemodynamic stability at baseline (peripheral oxygen saturation ≥95% and heart rate within age-appropriate limits).
• Ability to communicate sufficiently to complete study assessments.
• Provision of written informed consent by a parent or legal guardian.
• Provision of verbal assent by the child. -

You may not qualify if:

• Significant visual or hearing impairment.
• Head or facial wounds that prevent the use of virtual reality glasses.
• History of motion sickness or previous adverse reactions to virtual reality.
• Receipt of sedatives or systemic opioid analgesics within 6 hours prior to the procedure.
• Requirement for procedural sedation during wound care.
• Any clinical condition deemed 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: Due to the nature of the distraction interventions, participants and care providers were not blinded. Outcome assessment and data entry were performed by a research assistant who was blinded to group allocation.
• Purpose: TREATMENT
• 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 one of three parallel groups: standard care alone (control), standard care with distraction game cards, or standard care with immersive virtual reality glasses.

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: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)