Virtual Reality During Colonoscopy

NCT ID: NCT05723861

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2023-06-28

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.

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.

Conditions

Virtual Reality; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VR group

Participants will receive Virtual Reality intervention in addition to routine care during colonoscopy.

Group Type: EXPERIMENTAL

VR

Intervention Type: DEVICE

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.

Control group

Receive routine treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mahdi Shamali

Postdoc Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahdi Shamali, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte University Hospital

Hanne Konradsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte University Hospital

Locations

Department of Gastroenterology, Herlev and Gentofte Hospital

Copenhagen, , Denmark

Countries

Denmark

References

Shamali M, Vilmann P, Johansen NR, Konradsen H. Virtual reality intervention to improve quality of care during colonoscopy: a hybrid type 1 randomized controlled trial. Gastrointest Endosc. 2024 Nov;100(5):914-922.e2. doi: 10.1016/j.gie.2024.05.023. Epub 2024 Jun 6.

Reference Type: DERIVED

PMID: 38851457 (View on PubMed)

Other Identifiers

E 19215 09

Identifier Type: OTHER

Identifier Source: secondary_id

VR2023

Identifier Type: -

Identifier Source: org_study_id