Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy

Not Applicable

Recruiting

• Conditions: Pain; Colonoscopy

• Registration Number: NCT06279481
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.

Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.

Detailed Description

Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.

Study Timeline

• Study First Submitted: 2023-12-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-02-28
• Study Start: 2024-05-01
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Between 18 and 50 years of age
• Able to cooperate and complete the questionnaires independently
• Stable vital signs with no serious cardiovascular or cerebrovascular diseases
• Voluntary participation

Exclusion Criteria

• Severely impaired in vision or hearing to accommodate VR devices
• Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of Visual Analogue Scale Mean Scores by Groups	Evaluated immediately after colonoscopy.	Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome.

Secondary Outcome Measures

Name	Time	Method
Comparison of Vital Signs between Groups: Respiration Rate	Evaluated both before and every 3 minutes during colonoscopy.	All vital signs of patients will be measured by a same multifunctional ECG monitor.
Comparison of Vital Signs between Groups: Oxygen Saturation	Evaluated both before and every 3 minutes during colonoscopy.	All vital signs of patients will be measured by a same multifunctional ECG monitor.
Comparison of Vital Signs between Groups: Blood Pressure	Evaluated both before and every 3 minutes during colonoscopy.	All vital signs of patients will be measured by a same multifunctional ECG monitor.
Comparison of Adverse Effects in both groups	During and immediately after colonoscopy.	Any adverse effect (e.g. nausea, vomiting, headache, or dizziness) would be immediately recorded.
Comparison of State Trait Anxiety Inventory Mean Scores by Groups	Evaluated immediately both prior and after colonoscopy.	State Trait Anxiety Inventory evaluates anxiety with a scale containing 20 items, scoring between 20 points (no anxiety) to 80 points (high anxiety).
Comparison of Vital Signs between Groups: Pulse Rate	Evaluated both before and every 3 minutes during colonoscopy.	All vital signs of patients will be measured by a same multifunctional ECG monitor.
Comparison of Patient Satisfaction of Colonoscopy between Groups	Evaluated immediately after colonoscopy.	Patient satisfaction will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher satisfaction. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration.
Comparison of Patient Willingness of Future Colonoscopy between Groups	Evaluated immediately after colonoscopy.	Patient willingness to undergo future colonoscopies will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher willingness. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China