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OpenTrials
Completed

NCT Number: NCT05723861

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.

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Key information

Conditions

Virtual Reality Anxiety Disorders Colonoscopy Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

About this study

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:

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

Quantitative part:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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).

Secondary outcomes

  1. Patient satisfaction

    Time frame: 5 - 15 minutes after the colonoscopy is ended.

    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).

  2. Patient / healthcare professional experience with using VR during colonoscopy

    Time frame: 30 minutes - one week after the procedure

    Qualitative interview of some patients in the intervention group and and healthcare professionals.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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