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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279481
• Other study ID #: PUMCH-K2458
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Peking Union Medical College Hospital
• Contact: Yingyun Yang, MD
• Phone: 18510031805
• Email: yingyunyang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Pain

Intervention

Other:
• Nonpharmacological method
Virtual reality

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.