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 range6 Years – 15 Years

SexALL

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.

What they're measuring

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).

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).

Recovery Duration

Timeframe: Measured from the time of entry into the recovery room until discharge, assessed up to 300 minutes.

Trial details

NCT IDNCT07274111

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Gastrointestinal Endoscopy trials