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

NCT ID: NCT07274111

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality (VR) Intervention

Participants in this arm received a one-minute immersive Virtual Reality (VR) session prior to gastrointestinal endoscopy. Using a head-mounted display with age-appropriate preloaded environments (roller coaster, space, wildlife, travel scenes), the nurse assisted in headset fitting and adjustment. The VR session aimed to reduce pre-procedural anxiety and enhance comfort. All assessments and procedures were conducted following the same standardized schedule as the control group to ensure comparability.

Group Type: EXPERIMENTAL

Virtual Reality Head-Mounted Display

Intervention Type: BEHAVIORAL

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.

Standard Care (Control)

Participants in this arm received standard pre-procedural care without exposure to Virtual Reality. The usual preparation and education were provided by the endoscopist, anesthesiologist, and nurse according to hospital policy. Children underwent identical assessment points as the intervention group, including evaluation of anxiety, physiological stability, pain, and recovery time, to allow valid comparison between groups under consistent clinical conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Immersive VR Session

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Rasha Gad

Lecturer of pediatric Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rasha Gad, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Faculty of Nursing

Locations

Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

0493

Identifier Type: -

Identifier Source: org_study_id