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

NCT07274111 | Completed DMC

• 1 other identifier: 0493
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Endoscopy; Procedural Anxiety; Pain

Keywords

Pediatric Nursing; Virtual Reality (VR); Pediatric Endoscopy; Anxiety; Pain

Outcome Measures

Primary Outcomes (3)

• Change in Children's Anxiety Levels

  Anxiety levels was measured using the State-Trait Anxiety Inventory for Children (STAI-CH). Both the trait and state subscales was used. The primary outcome was the difference in state anxiety scores before and during the intervention between the VR and control groups. Each item is scored on a 3-point Likert scale, with total scores ranging from 20 to 60, where higher scores indicate greater anxiety.

  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

  pain will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). The outcome represents the mean difference in pain levels between the VR and control groups following the endoscopic procedure.

  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

  Recovery time will be measured as the total duration of each child's stay in the recovery room (recorded in minutes and presented in hours) from entry into the recovery unit until discharge criteria are met. The outcome represents the mean recovery duration between the VR and control groups.

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

Secondary Outcomes (3)

• Change in respiratory rate

  Respiratory rate was assessed immediately before entering the endoscopy room (pre-procedure) and again prior to anesthesia induction (peri-procedure).

• Change in heart rate

  Heart rate was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).

• Change in Oxygen Saturation

  Oxygen saturation was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).

Study Arms (2)

Virtual Reality (VR) Intervention

EXPERIMENTAL

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.

Behavioral: Virtual Reality Head-Mounted Display

Standard Care (Control)

NO INTERVENTION

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.

Interventions

Virtual Reality Head-Mounted Display 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.

Also known as: Immersive VR Session

Virtual Reality (VR) Intervention

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rasha Gad, Ph.D

  Mansoura University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind randomized controlled trial. Participants and clinical staff were aware of group allocation due to the visible nature of the VR intervention. However, the statistician analyzing the data was blinded to group assignments to minimize assessment bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric Nursing

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: June 3, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)