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

Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Colonoscopy
• Intervention / Treatment: Other: Nonpharmacological method

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 Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingyun Yang, MD; Phone Number: +86 18510031805; Email: yingyunyang@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; The virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation.	Other: Nonpharmacological method; Virtual reality
No Intervention: Control; Patients undergo traditional colonoscopy procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Visual Analogue Scale Mean Scores by Groups	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.	Evaluated immediately after colonoscopy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of State Trait Anxiety Inventory Mean Scores by Groups	State Trait Anxiety Inventory evaluates anxiety with a scale containing 20 items, scoring between 20 points (no anxiety) to 80 points (high anxiety).	Evaluated immediately both prior and after colonoscopy.
Comparison of Vital Signs between Groups: Pulse Rate	All vital signs of patients will be measured by a same multifunctional ECG monitor.	Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Blood Pressure	All vital signs of patients will be measured by a same multifunctional ECG monitor.	Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Respiration Rate	All vital signs of patients will be measured by a same multifunctional ECG monitor.	Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Oxygen Saturation	All vital signs of patients will be measured by a same multifunctional ECG monitor.	Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Patient Satisfaction of Colonoscopy between Groups	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.	Evaluated immediately after colonoscopy.
Comparison of Patient Willingness of Future Colonoscopy between Groups	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.	Evaluated immediately after colonoscopy.
Comparison of Adverse Effects in both groups	Any adverse effect (e.g. nausea, vomiting, headache, or dizziness) would be immediately recorded.	During and immediately after colonoscopy.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Yingyun Yang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PUMCH-K2458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No