Procedural Pain ReliefNCT07824427
AI-Generated Video Distraction Via Virtual Reality for Fear and Pain During Pediatric Circumcision
A study testing AI-Generated Video Distraction via Virtual Reality in people with Procedural Pain Relief and Virtual Reality, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Read more about this study
- Who is it for?
- Ages 4 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain Relief, Virtual Reality, Fear
- What is being tested?
- AI-Generated Video Distraction via Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 23 Sep 2026
- 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 4 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Male children aged 4 to 12 years.
- Children scheduled to undergo circumcision.
- Participation in the study with parental consent.
Who cannot join
- Presence of a neurodevelopmental disorder.
- Visual or hearing impairment that prevents viewing the video or completing the scales.
- History of epilepsy.
- History of motion sickness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Dursun Odabaş Medical Center
Van, Van, 65080
About this study
Official title: AI-Generated Video Distraction Via Virtual Reality for Procedural Fear and Pain in Pediatric Circumcision: A Randomized Controlled Trial
This randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Children in the intervention group received AI-generated video distraction via virtual reality, whereas children in the control group received routine care. Pain and emotional responses were assessed from the perspectives of the child, parent, and nurse. Physiological parameters were also measured before and after the procedure. The study aimed to determine whether AI-generated video distraction delivered via virtual reality reduces procedural fear and pain during pediatric circumcision.
- Conditions
- Procedural Pain Relief, Virtual Reality, Fear, Child, Digital Health, Generative Artificial Intelligence
- Being tested
- AI-Generated Video Distraction via Virtual Reality
- Keywords
- Circumcision, Male, Virtual Reality, Generative Artificial Intelligence, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Video Distraction via Virtual RealityBehavioural
Artificial intelligence-generated video content is presented through a virtual reality headset as a distraction intervention for children undergoing circumcision. The intervention is intended to reduce procedural fear and pain.
| Study group | Role | What they receive |
|---|---|---|
| AI-Generated Video Distraction via Virtual Reality | Experimental | Children in the intervention group watched a 3-minute artificial intelligence-generated video through a virtual reality headset before circumcision, in addition to routine care. Receives: Behavioral: AI-Generated Video Distraction via Virtual Reality |
| Control Group | No intervention | Children in the control group received routine care without the virtual reality video intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores at the Post-Test Assessment
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity. The child, parent, and nurse independently rated the child's pain. Baseline pain was also assessed 30 minutes before circumcision in both groups.
Measured: 1 hour after circumcision.
Secondary outcomes (6)
Preoperative Fear Scores
Child-reported fear was assessed using the six-face Scary Scale, with scores ranging from 0 to 10. Higher scores indicate greater fear. Separate parent and nurse ratings of the child's fear were also recorded.
Measured: Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.
Preoperative State Anxiety Scores
Child-reported state anxiety was assessed using the Children's Anxiety Meter-State, a thermometer-like scale ranging from 0 to 10. Higher scores indicate greater anxiety. Separate parent and nurse ratings of the child's anxiety were also recorded.
Measured: Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.
Heart Rate
Heart rate was measured in beats per minute in both groups.
Measured: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Body Temperature
Body temperature was measured in degrees Celsius in both groups.
Measured: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2) was measured as a percentage in both groups.
Measured: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Respiratory Rate
Respiratory rate was measured in breaths per minute in both groups.
Measured: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jun 2026
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Pain ReliefStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet bulduk, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824427
- Sponsor's protocol ID
- 2025/10-09
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2026
- Last updated
- 9 Oct 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 publicly shared due to participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Generated Video Distraction Via Virtual Reality for Procedural Fear and Pain in Pediatric Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07824427
- Acronym / sponsor ID
- 2025/10-09
- Conditions
- Procedural Pain Relief, Virtual Reality, Fear, Child, Digital Health, Generative Artificial Intelligence
- Keywords
- Circumcision, Male, Virtual Reality, Generative Artificial Intelligence, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 17 Sep 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 randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Children in the intervention group received AI-generated video distraction via virtual reality, whereas children in the control group received routine care. Pain and emotional responses were assessed from the perspectives of the child, parent, and nurse. Physiological parameters were also measured before and after the procedure. The study aimed to determine whether AI-generated video distraction delivered via virtual reality reduces procedural fear and pain during pediatric circumcision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Generated Video Distraction via Virtual Reality | Experimental | Behavioral: AI-Generated Video Distraction via Virtual RealityChildren in the intervention group watched a 3-minute artificial intelligence-generated video through a virtual reality headset before circumcision, in addition to routine care. |
| Control Group | No intervention | –Children in the control group received routine care without the virtual reality video intervention. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male children aged 4 to 12 years.
- Children scheduled to undergo circumcision.
- Participation in the study with parental consent.
Key exclusion criteria (4 listed)
- Presence of a neurodevelopmental disorder.
- Visual or hearing impairment that prevents viewing the video or completing the scales.
- History of epilepsy.
- History of motion sickness.
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 |
|---|---|---|
| AI-Generated Video Distraction via Virtual RealityArtificial intelligence-generated video content is presented through a virtual reality headset as a distraction intervention for children undergoing circumcision. The intervention is intended to reduce procedural fear and pain. | Behavioural | AI-Generated Video Distraction via Virtual Reality |
Primary outcome
Pain Scores at the Post-Test Assessment
Time frame: 1 hour after circumcision.
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity. The child, parent, and nurse independently rated the child's pain. Baseline pain was also assessed 30 minutes before circumcision in both groups.
6 secondary outcomes
Preoperative Fear Scores
Time frame: Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.
Preoperative State Anxiety Scores
Time frame: Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.
Heart Rate
Time frame: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Body Temperature
Time frame: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Peripheral Oxygen Saturation
Time frame: 30 minutes before circumcision and 1 hour after circumcision in both groups.
Respiratory Rate
Time frame: 30 minutes before circumcision and 1 hour after circumcision in both groups.
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 9 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant privacy and confidentiality considerations.
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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 AI-Generated Video Distraction via Virtual Reality in people with Procedural Pain Relief and Virtual Reality, run by Yuzuncu Yil 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 3 inclusion and 4 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 9 Oct 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?
Pain Scores at the Post-Test Assessment (time frame: 1 hour after circumcision.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.