Clinical trial NCT06279481: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy
Official title: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Colonoscopy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-centered, prospective, randomized controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of Visual Analogue Scale Mean Scores by Groups
timeFrame: Evaluated immediately after colonoscopy.
Secondary outcomes:
measure: Comparison of State Trait Anxiety Inventory Mean Scores by Groups
timeFrame: Evaluated immediately both prior and after colonoscopy.
measure: Comparison of Vital Signs between Groups: Pulse Rate
timeFrame: Evaluated both before and every 3 minutes during colonoscopy.
measure: Comparison of Vital Signs between Groups: Blood Pressure
timeFrame: Evaluated both before and every 3 minutes during colonoscopy.
measure: Comparison of Vital Signs between Groups: Respiration Rate
timeFrame: Evaluated both before and every 3 minutes during colonoscopy.
measure: Comparison of Vital Signs between Groups: Oxygen Saturation
timeFrame: Evaluated both before and every 3 minutes during colonoscopy.
measure: Comparison of Patient Satisfaction of Colonoscopy between Groups
timeFrame: Evaluated immediately after colonoscopy.
measure: Comparison of Patient Willingness of Future Colonoscopy between Groups
timeFrame: Evaluated immediately after colonoscopy.
measure: Comparison of Adverse Effects in both groups
timeFrame: During and immediately after colonoscopy.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yingyun Yang, MD
role: STUDY_DIRECTOR
References: