NCT07274111

Virtual Reality as a Nursing Intervention for Anxiety and Pain in Pediatric Endoscopy

Virtual Reality to Manage Pediatric Gastrointestinal Endoscope-related Anxiety, Post Procedural Pain, and Recovery Time: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective randomized controlled experimental study investigates the use of virtual reality (VR) as a non-pharmacological nursing intervention to reduce anxiety and enhance recovery outcomes in pediatric patients undergoing gastrointestinal endoscopic procedures. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit of Mansoura University Children's Hospital, located in Mansoura City, Dakahlia Governorate, Egypt. Participants include children aged 6-15 years scheduled for their first GI endoscopy who demonstrate an interest in technology and consent to participate. Children with seizure disorders, cardiac diseases, visual or hearing impairments, developmental delays, motion sickness, or those undergoing chemotherapy are excluded. Following ethical approval and informed consent, participants are randomly allocated in a 1:1 ratio to either the VR intervention or control group. Both groups receive a standardized pre-procedural education session delivered by the endoscopist, anesthesiologist, and nurse. In the waiting area, baseline assessments include demographic characteristics, state and trait anxiety (using the State-Trait Anxiety Inventory for Children), physiological parameters (respiratory rate, heart rate, and oxygen saturation), and pain level (using the Wong-Baker FACES Pain Rating Scale). Children in the VR group wear a head-mounted display containing preloaded age-appropriate immersive environments, such as virtual roller coasters, space exploration, wildlife parks, and travel scenes, for one minute before entering the endoscopy room. The nurse assists with headset adjustment and ensures proper device hygiene. The control group receives standard pre-procedural care without VR exposure. Anxiety and physiological indicators are reassessed in the endoscopy room prior to anesthesia induction. Post-procedural pain and recovery duration (time spent in the recovery room until discharge) are recorded afterward. Data are analyzed using SPSS version 26, employing descriptive statistics, independent t-tests, chi-square tests, and non-parametric alternatives where appropriate. Statistical significance is set at p \< .05. This trial aligns with CONSORT reporting standards and aims to provide evidence on the clinical value of VR as an effective, child-friendly nursing intervention for anxiety and pain management in pediatric endoscopy settings.

Conditions

• Gastrointestinal Endoscopy
• Procedural Anxiety
• Pain

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Reality Head-Mounted Display	Children assigned to the experimental arm received a one-minute immersive session using a virtual reality head-mounted display before gastrointestinal endoscopy. The device contained age-appropriate preloaded applications featuring realistic visual and auditory environments, such as roller coasters, space exploration, wildlife parks, and travel scenes. The nurse assisted each child in properly fitting and adjusting the headset to ensure comfort and clarity. The VR session was administered immediately before transfer to the endoscopy room to reduce pre-procedural anxiety and enhance relaxation.

Timeline

• Start date: 2025-06-03
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: Egypt