Clinical trial NCT05723861: Virtual Reality During Colonoscopy
Official title: Virtual Reality During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Colonoscopy
Keywords: Colonoscopy
Virtual Reality
Anxiety
Pain
Patient comfort
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient pain before colonoscopy procedure
timeFrame: 5 - 15 minutes before starting colonoscopy.
measure: Patient pain during colonoscopy procedure
timeFrame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
measure: Patient pain after colonoscopy procedure
timeFrame: 5 - 15 minutes after the colonoscopy is ended.
measure: Patient anxiety before colonoscopy procedure
timeFrame: 5 - 15 minutes before starting colonoscopy.
measure: Patient anxiety after colonoscopy procedure
timeFrame: 5 - 15 minutes after the colonoscopy is ended.
measure: Patient comfort during colonoscopy procedure
timeFrame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
measure: Patient comfort after colonoscopy procedure
timeFrame: 5 - 15 minutes after the colonoscopy is ended.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 5 - 15 minutes after the colonoscopy is ended.
measure: Patient / healthcare professional experience with using VR during colonoscopy
timeFrame: 30 minutes - one week after the procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Gastroenterology, Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev and Gentofte University Hospital
name: Mahdi Shamali, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev and Gentofte University Hospital
name: Hanne Konradsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: