Virtual Reality as a Nursing Intervention for Anxiety and Pain in Pediatric Endoscopy (NCT07274111) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality as a Nursing Intervention for Anxiety and Pain in Pediatric Endoscopy
Egypt66 participantsStarted 2025-06-03
Plain-language summary
This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR) intervention in managing anxiety, post-procedural pain, and recovery time among pediatric patients undergoing gastrointestinal (GI) endoscopy. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit, Mansoura University Children's Hospital, Egypt. Eligible children are randomly assigned to either a VR intervention group or a control group receiving standard care. The VR group uses a head-mounted display featuring age-appropriate immersive applications before endoscopy. Measured outcomes include anxiety levels, physiological stability, post-procedural pain, and recovery duration. The study follows CONSORT guidelines and ethical principles outlined in the Declaration of Helsinki.
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 6-15 years scheduled to undergo a gastrointestinal endoscopic procedure.
* First-time endoscopy patients (no prior endoscopic experience).
* Willing to participate, with informed consent from parents/guardians and child assent.
Interest in technology and ability to tolerate a brief VR experience.
\- Physically and cognitively able to complete the anxiety and pain assessment tools (STAI-CH and FACES scales).
Exclusion Criteria:
* Children with a known history of seizure disorders or cardiac diseases.
* Presence of active infection, burns, or trauma involving the periorbital skin, eyes, nasal bridge, external ear, scalp, or hair.
* Visual or hearing impairments that would interfere with VR use.
* Developmental delays (including autism spectrum disorders) that significantly limit cooperation or understanding of instructions.
* Active psychosis or symptoms of intoxication.
* History of severe motion sickness.
* Children currently undergoing chemotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Children's Anxiety Levels
Timeframe: Trait subscale was assessed only prior to the child's entry while the State subscale was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).
2
Change in Pain Level
Timeframe: Two time points: pre-procedural pain level (immediately before entering the endoscopy room) and post-procedural pain level (30 minutes post-procedure in the recovery unit).
3
Recovery Duration
Timeframe: Measured from the time of entry into the recovery room until discharge, assessed up to 300 minutes.