Virtual Reality During Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Virtual Reality
• Intervention / Treatment: Device: VR

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.

Implementation work package

Qualitative part:

1. To explore facilitators/barriers to adoption and implementing using VR during colonoscopy.
2. To explore the facilitators/barriers to sustaining using VR during colonoscopy after the study was completed.

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2730
    • Department of Gastroenterology, Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥ 18
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR group; Participants will receive Virtual Reality intervention in addition to routine care during colonoscopy.	Device: VR; 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.
No Intervention: Control group; Receive routine treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	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).	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).	5 - 15 minutes after the colonoscopy is ended.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	30 minutes - one week after the procedure

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: University Hospital Bispebjerg and Frederiksberg
• Investigators: Principal Investigator: Mahdi Shamali, PhD, Herlev and Gentofte University Hospital; Principal Investigator: Hanne Konradsen, PhD, Herlev and Gentofte University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Virtual Reality; Colonoscopy; Patient comfort
• Other Study ID Numbers: VR2023; E 19215 09 (Other Identifier: Herlev Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No