- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335666
Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care (VR-WOUND)
Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Open wound care procedures are common in pediatric emergency settings and are frequently associated with fear, anxiety, pain, and physiological stress in children. These responses may interfere with cooperation during treatment and negatively affect children's short- and long-term perceptions of healthcare. Although pharmacological approaches can reduce pain, non-pharmacological interventions are increasingly recommended as complementary strategies to minimize distress without additional medical risk.
Distraction techniques represent one of the most widely used non-pharmacological approaches in pediatric care. Immersive virtual reality (VR) has gained attention as a promising distraction method due to its ability to provide multisensory engagement and strong attentional capture. By immersing children in an interactive virtual environment, VR may reduce awareness of painful stimuli and procedural threat. In contrast, distraction game cards offer a simple, low-cost alternative that engages children cognitively through visual search and pattern recognition tasks. Despite growing evidence supporting both approaches, direct comparisons between immersive VR and low-cost distraction methods during pediatric wound care remain limited.
This study is designed as a single-center, parallel-group randomized controlled trial conducted in the pediatric emergency department of Agri Training and Research Hospital in Turkey. Children aged 5-10 years who require open wound care, including cleansing, dressing, or suturing, are eligible to participate. Following informed consent from parents or guardians and assent from children, participants are randomly allocated in a 1:1:1 ratio to one of three groups: standard wound care alone (control group), standard care with distraction game cards, or standard care with immersive virtual reality glasses.
All participants receive wound care according to institutional clinical protocols. Children in the virtual reality group wear VR glasses displaying age-appropriate immersive content throughout the procedure. Children in the game card group engage with illustrated distraction cards facilitated by a trained researcher. Psychological outcomes, including fear, state anxiety, and pain, are assessed immediately before and shortly after the procedure using validated child-appropriate scales. Physiological responses, including heart rate and peripheral oxygen saturation, are measured concurrently using a pulse oximeter.
The primary objective of the study is to compare post-procedural fear, anxiety, and pain levels between groups. Secondary objectives include evaluation of within-group changes and comparison of physiological stress indicators across interventions. By directly comparing immersive virtual reality with a simple, low-cost distraction method, this study aims to provide clinically relevant evidence to inform the selection of effective, feasible, and scalable non-pharmacological interventions for pediatric wound care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
AĞRI
-
Merkez, AĞRI, Turkey (Türkiye), 04100
- Ağrı Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:Children aged 5 to 10 years.
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. -
Exclusion Criteria:Presence of neurodevelopmental disorders or communication impairments that could interfere with study assessments.
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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Care Control Group
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.
|
|
|
Experimental: Distraction Game Card Group
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.
|
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.
|
|
Experimental: Virtual Reality Distraction Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural Fear
Time Frame: Immediately before the procedure and within 5 minutes after completion of wound care
|
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
Time Frame: Immediately before the procedure and within 5 minutes after completion of wound care
|
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
Time Frame: Immediately before the procedure and within 5 minutes after completion of wound care
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Immediately before the procedure and within 5 minutes after completion of wound care
|
Physiological stress response measured as heart rate (beats per minute) using a fingertip pulse oximeter during a stable 30-second recording period.
|
Immediately before the procedure and within 5 minutes after completion of wound care
|
|
Peripheral Oxygen Saturation (SpO₂)
Time Frame: Immediately before the procedure and within 5 minutes after completion of wound care
|
Physiological response measured as peripheral oxygen saturation (%) using a fingertip pulse oximeter during a stable 30-second recording period.
|
Immediately before the procedure and within 5 minutes after completion of wound care
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR-WOUNDCARE-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Procedural Pain
-
Defense and Veterans Center for Integrative Pain...DepomedCompletedMinor Procedural PainUnited States
-
IRCCS Burlo GarofoloCompletedProcedural Pain ReliefItaly
-
IWK Health CentreCompletedNeonatal Procedural Pain ResponseCanada
-
Istanbul UniversityNot yet recruitingProcedural Pain | Procedural Anxiety | Breast Imaging
-
Hamad Medical CorporationRecruitingProcedural Pain | Procedural AnxietyQatar
-
University of UtahCompleted
-
Aynur Aytekin OzdemirCompletedProcedural Pain Relief | Fear PainTurkey
-
Hakkari UniversitesiNot yet recruitingPain | Anxiety | Fear | Procedural Pain | Procedural Anxiety
-
Hayatabad Medical ComplexNot yet recruiting
-
Ain Shams UniversityRecruitingProcedural PainEgypt
Clinical Trials on Distraction Game Cards
-
Bilecik Seyh Edebali UniversitesiCompleted
-
Burdur Mehmet Akif Ersoy UniversityCompletedAnxiety | Acute Pain | Fear | Virtual Reality | Nursing Caries | Children, Only | Distraction Cards | KaleidoscopeTurkey
-
Dilek Kucuk AlemdarCompletedChild | Pain Management | Fear AnxietyTurkey
-
Indira Gandhi Institute of Dental ScienceUnknown
-
Mine Gokduman KelesRecruitingPain | Anxiety | Virtual Reality | Distraction CardsTurkey
-
Istanbul Medeniyet UniversityCompletedProcedural Pain | Procedural AnxietyTurkey
-
Uskudar UniversityNot yet recruitingRespiratory Tract Diseases | Respiratory Infections, Acute
-
Turkish Ministry of Health, Kahramanmaras Provincial...CompletedCervical Cancer | Smear LayerTurkey
-
University Hospital TuebingenActive, not recruiting
-
VA Office of Research and DevelopmentCompletedFeasibility | Suicide Risk | Acceptability | Social Connectedness | Thwarted Belongingness | Perceived BurdensomenessUnited States