Virtual Reality During Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Herlev and Gentofte Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Patient pain before colonoscopy procedure
Study Overview
Brief Summary
This project will use a randomized controlled trial to test the effect of using Virtual Reality on pain, anxiety, patients' comfort, and satisfaction during colonoscopy. Patients will use a virtual reality head-mounted display and choose a visualized VR content to watch during colonoscopy. Colonoscopy will be initiated without standard sedatives and narcotics and using virtual reality distraction for as long as the patient would like (for a maximum of 20 minutes). Participants could opt out and/or request standard medications for pain at any time before or during the procedure.
Detailed Description
This project aims to investigate the clinical effectiveness and implementation potential of using VR during colonoscopy using a hybrid type 1 effectiveness-implementation design through 2 work packages. The first work package will investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy using a multicenter parallel randomized controlled, open-label trial. It will also be a qualitative interview to explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
The second work package will evaluate the implementation process using mix method to understand why the intervention is (or is not) more effective than usual care, whether high intervention fidelity is achieved, what barriers and facilitators there are, how these may translate into real-world implementation, and what modifications can be made to maximize implementation success. This will be achieved using quantitative and qualitative approaches with a focus on the process evaluation around the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Quantitative (e.g., quantitative analysis of patient participation rate and reasons for refusal assessment or ineligibility) and qualitative (e.g., qualitative interview of facilitators/barriers to implementing VR) data analyses will be combined to conclude the reach, adoption, implementation, and maintenance of the intervention.
The specific aims of the project will be pursued through 2 work packages and include:
Intervention effectiveness work package Study I: To investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy.
Study II: To explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •any elective indication of colonoscopy
Exclusion Criteria
- •having visual impairments,
- •having dementia
- •limited Danish language skills
- •a high tendency to travel sickness
- •having skin disease in the facial area
- •having epilepsy
Arms & Interventions
VR group
Participants will receive Virtual Reality intervention in addition to routine care during colonoscopy.
Intervention: VR (Device)
Control group
Receive routine treatment.
Outcomes
Primary Outcomes
Patient pain before colonoscopy procedure
Time Frame: 5 - 15 minutes before starting colonoscopy.
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient anxiety after colonoscopy procedure
Time Frame: 5 - 15 minutes after the colonoscopy is ended.
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Patient comfort after colonoscopy procedure
Time Frame: 5 - 15 minutes after the colonoscopy is ended.
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
Patient anxiety before colonoscopy procedure
Time Frame: 5 - 15 minutes before starting colonoscopy.
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Patient pain during colonoscopy procedure
Time Frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient pain after colonoscopy procedure
Time Frame: 5 - 15 minutes after the colonoscopy is ended.
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient comfort during colonoscopy procedure
Time Frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
Secondary Outcomes
- Patient / healthcare professional experience with using VR during colonoscopy(30 minutes - one week after the procedure)
- Patient satisfaction(5 - 15 minutes after the colonoscopy is ended.)
Investigators
Mahdi Shamali
Postdoc Researcher
Herlev and Gentofte Hospital