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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Virtual reality
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGComparison 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.
Time frame: Evaluated immediately after colonoscopy.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During and immediately after colonoscopy.