Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Comparison of Visual Analogue Scale Mean Scores by Groups
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Comparison of Visual Analogue Scale Mean Scores by Groups
Time Frame: 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 Outcomes
- Comparison of Vital Signs between Groups: Respiration Rate(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Vital Signs between Groups: Oxygen Saturation(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Vital Signs between Groups: Blood Pressure(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Adverse Effects in both groups(During and immediately after colonoscopy.)
- Comparison of State Trait Anxiety Inventory Mean Scores by Groups(Evaluated immediately both prior and after colonoscopy.)
- Comparison of Vital Signs between Groups: Pulse Rate(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Patient Satisfaction of Colonoscopy between Groups(Evaluated immediately after colonoscopy.)
- Comparison of Patient Willingness of Future Colonoscopy between Groups(Evaluated immediately after colonoscopy.)