Pediatric WoundsVR-WOUNDNCT07335666
Virtual Reality Versus Game Card Distraction During Pediatric Wound Care
A study testing Distraction Game Cards and Virtual Reality Distraction in people with Pediatric Wounds and Procedural Pain, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Pediatric Wounds, Procedural Pain, Procedure-Related Anxiety
- What is being tested?
- Distraction Game Cards and Virtual Reality Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
Center, AĞRI, 04100
About this study
Official title: Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care
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.
Read the detailed description
Open wound care procedures may cause fear, anxiety, pain, and physiological stress in children. This study was conducted in the pediatric emergency department of Ağrı Training and Research Hospital, Turkey, between April and May 2023.
Children aged 5-10 years who required open wound care were randomly allocated in a 1:1:1 ratio to standard care alone, standard care plus distraction game cards, or standard care plus immersive virtual reality. Standard care included wound cleansing, debridement, suturing when clinically indicated, and dressing.
In the game card group, a trained researcher used laminated illustrated cards with visual-search and pattern-recognition tasks and provided structured prompts throughout the procedure. In the virtual reality group, children viewed a preset sequence of passive, non-interactive, age-appropriate 360-degree three-dimensional audiovisual videos using a smartphone-based virtual reality headset throughout the procedure.
Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were measured immediately before wound care and within 5 minutes after completion. The study compared psychological and physiological responses among the three groups.
- Being tested
- Distraction Game Cards, Virtual Reality Distraction
- Keywords
- Virtual Reality, Distraction Techniques, Game Card Distraction, Immersive Distraction, Pediatric Wound Care, Child-Centered Care, Non-Pharmacological Intervention, Procedural Pain Management, Procedural Anxiety
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction Game CardsBehavioural
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.
Virtual Reality DistractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual Reality Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before wound care and within 5 minutes after completion of wound care
Secondary outcomes (2)
Heart Rate
Heart rate was measured in beats per minute using a fingertip pulse oximeter after a stable 30-second recording.
Measured: Immediately before wound care and within 5 minutes after completion of wound care
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation was measured as a percentage using a fingertip pulse oximeter after a stable 30-second recording.
Measured: Immediately before wound care and within 5 minutes after completion of wound care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Apr 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335666
- Sponsor's protocol ID
- VR-WOUNDCARE-04
- Acronym
- VR-WOUND
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the parental consent process did not authorize sharing outside the research team and the small, single-center pediatric sample presents a risk of participant re-identification. Aggregate results will be reported in publications.
Publications
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.
PubMed 35753857Olbrecht 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.
PubMed 34175959Thybo 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.
PubMed 35898121Sanchez-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.
PubMed 39201910Addab 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.
PubMed 35068011
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care
- ClinicalTrials.gov ID
- NCT07335666
- Acronym / sponsor ID
- VR-WOUND / VR-WOUNDCARE-04
- Keywords
- Virtual Reality, Distraction Techniques, Game Card Distraction, Immersive Distraction, Pediatric Wound Care, Child-Centered Care, Non-Pharmacological Intervention, Procedural Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Open wound care procedures may cause fear, anxiety, pain, and physiological stress in children. This study was conducted in the pediatric emergency department of Ağrı Training and Research Hospital, Turkey, between April and May 2023.
Children aged 5-10 years who required open wound care were randomly allocated in a 1:1:1 ratio to standard care alone, standard care plus distraction game cards, or standard care plus immersive virtual reality. Standard care included wound cleansing, debridement, suturing when clinically indicated, and dressing.
In the game card group, a trained researcher used laminated illustrated cards with visual-search and pattern-recognition tasks and provided structured prompts throughout the procedure. In the virtual reality group, children viewed a preset sequence of passive, non-interactive, age-appropriate 360-degree three-dimensional audiovisual videos using a smartphone-based virtual reality headset throughout the procedure.
Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were measured immediately before wound care and within 5 minutes after completion. The study compared psychological and physiological responses among the three groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Distraction Game CardsParticipants 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. |
| Virtual Reality Distraction Group | Experimental | Behavioral: Virtual Reality DistractionParticipants received standard wound care plus passive immersive audiovisual virtual reality delivered using a smartphone-based headset throughout the procedure. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction Game CardsThe 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. | Behavioural | Distraction Game Card Group |
| Virtual Reality DistractionA 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. | Behavioural | Virtual Reality Distraction Group |
Primary outcome
Children's Fear Scale Score
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
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.
State-Trait Anxiety Inventory for Children-State Subscale Score
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
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.
Wong-Baker FACES Pain Rating Scale Score
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
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.
2 secondary outcomes
Heart Rate
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Peripheral Oxygen Saturation (SpO₂)
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 35753857Kaya 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.
- Background: PubMed 34175959Olbrecht 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.
- Background: PubMed 35898121Thybo 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.
- Background: PubMed 39201910Sanchez-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.
- Background: PubMed 35068011Addab 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the parental consent process did not authorize sharing outside the research team and the small, single-center pediatric sample presents a risk of participant re-identification. Aggregate results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction Game Cards and Virtual Reality Distraction in people with Pediatric Wounds and Procedural Pain, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Fear Scale Score (time frame: Immediately before wound care and within 5 minutes after completion of wound care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07335666, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.