Artificial Intelligence-Based Virtual Reality on Patient With Upper Gastrointestinal Endoscopy

NCT07848009 | Completed DMC

• 1 other identifier: 1000/4/3/196/26
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates whether an artificial intelligence-based virtual reality (AI-VR) relaxation intervention can improve patient outcomes during upper gastrointestinal endoscopy. Patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an AI-VR intervention group or a routine-care control group. Participants in the intervention group will receive a 10-15-minute AI-VR relaxation session immediately before the endoscopy, while participants in the control group will receive routine care. The study will assess patients' anxiety, pain perception, physiological parameters, and satisfaction in relation to the endoscopy procedure. The findings will help determine whether AI-VR can improve patient comfort and the overall endoscopy experience.

Conditions

Patient Anxiety During Upper Gastrointestinal Endoscopy

Keywords

Patient Anxiety Pain Upper Gastrointestinal Endoscopy Artificial Intelligence Virtual Reality AI-Based Virtual Reality Anxiety Management Pain Management

Outcome Measures

Primary Outcomes (1)

• Patient Anxiety During Upper Gastrointestinal Endoscopy

  Patient anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). Anxiety scores will be compared between the artificial intelligence-based virtual reality intervention group and the routine-care control group to evaluate the effect of the intervention on patient anxiety during upper gastrointestinal endoscopy. The STAI consists of 20 items for assessing state anxiety, with total scores ranging from 20 to 80; higher scores indicate greater anxiety.

  Anxiety (STAI) Baseline (pre-intervention) and immediately after the endoscopy procedure Pain intensity (VAS) Immediately after the endoscopy procedure Patient satisfaction (PSQ) Immediately after the endoscopy procedure Physiological parameters

Study Arms (2)

AI-Based Virtual Reality Group

EXPERIMENTAL

Artificial Intelligence-Based Virtual Reality Relaxation

Behavioral: Artificial Intelligence-Based Virtual Reality Relaxation

Routine Care Control Group

NO INTERVENTION

non

Interventions

Artificial Intelligence-Based Virtual Reality Relaxation BEHAVIORAL

Artificial Intelligence-Based Virtual Reality Relaxation

AI-Based Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are within the prespecified age range for the study (\[insert minimum and maximum age
• Are scheduled to undergo elective upper gastrointestinal endoscopy.
• Are able to understand the study procedures and communicate effectively.
• Are willing to participate in the study and provide informed consent.

You may not qualify if:

• Participants will be excluded if they:
• Have a condition that prevents them from safely participating in the virtual reality intervention.
• Have significant visual, auditory, cognitive, or neurological impairment that would interfere with the use of the virtual reality intervention or completion of the study assessments.
• Have previously participated in this study.
• Are unable or unwilling to provide informed consent.
• Require an urgent or emergency upper gastrointestinal endoscopy.

Sponsors & Collaborators

• Al-Zaytoonah University of Jordan: lead

Study Sites (1)

Al zaytoonah University

Amman, 00000, Jordan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessment was performed by an assessor who was blinded to participants' group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Community Health Nursing

Model Details: This is a two-arm, parallel-group randomized controlled trial. Eligible participants undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an artificial intelligence-based virtual reality intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-based virtual reality relaxation session before upper gastrointestinal endoscopy, while the control group will receive routine care.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start: January 4, 2026
• Primary Completion: January 5, 2026
• Study Completion: March 7, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)