An interventional study of VR in Virtual Reality and Colonoscopy, sponsored by Herlev and Gentofte Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Implementation work package
Qualitative part:
Quantitative part:
1) To examine the potential of using VR under colonoscopy for reach and adoption.
Participants will be recruited from adult patients referred to the two outpatient Endoscopy Units. Patients who meet the inclusion criteria and give written consent will be consecutively enrolled in the trial. These patients will be randomly allocated to an experimental group (using VR), or a control group (routine care). Outcomes will be measured immediately before, after, and/or during the procedure.
Some patients in the intervention group and healthcare professionals will be asked to participate in a qualitative interview to share their experiences of using VR under colonoscopy and to evaluate the implementation process.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Herlev and Gentofte Hospital is the lead sponsor of 74 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Participants will receive Virtual Reality intervention in addition to routine care during colonoscopy.
Device: VR
Receive routine treatment.
We will use the Pico Headset, a three-dimensional Gear with a connected tablet, and will be positioned on the head with elastic straps. Patients will be instructed about the VR device before their procedure and virtual experiences will initiate just before colonoscope insertion and continuously delivered throughout the procedure for max of 20 minutes. Patients will experience max of 20 minutes of VR and if colonoscopy lasts longer than 20 min, the remaining time of colonoscopy will be performed without using VR. The visualized content of VR will be chosen by the participants among three available contents including beach, nature, or mountain with relaxing music. Participants could opt out and/or request standard medications for pain at any time before or during the procedure.
Patient pain before colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Time frame: 5 - 15 minutes before starting colonoscopy.
Patient pain during colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Time frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient pain after colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient anxiety before colonoscopy procedure
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.
Time frame: 5 - 15 minutes before starting colonoscopy.
Patient anxiety after colonoscopy procedure
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.
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient comfort during colonoscopy procedure
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).
Time frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient comfort after colonoscopy procedure
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).
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient satisfaction
Patient satisfaction with the procedure will be measured using an 11-point numeric rating scale ranging from 0 (no satisfaction at all) to 10 (definitely satisfied).
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient / healthcare professional experience with using VR during colonoscopy
Qualitative interview of some patients in the intervention group and and healthcare professionals.
Time frame: 30 minutes - one week after the procedure
Plan to share: No
Ran from Mar 2023 to primary completion in Jun 2023, 2 months.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 2 months is below that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Herlev and Gentofte Hospital