Virtual Reality During Colonoscopy

NCT05723861 | Completed DMC

• 2 other identifiers: VR2023E 19215 09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Colonoscopy

Keywords

Colonoscopy; Virtual Reality; Anxiety; Pain; Patient comfort

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Patient satisfaction

  5 - 15 minutes after the colonoscopy is ended.

• Patient / healthcare professional experience with using VR during colonoscopy

  30 minutes - one week after the procedure

Study Arms (2)

VR group

EXPERIMENTAL

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

Device: VR

Control group

NO INTERVENTION

Receive routine treatment.

Interventions

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.

VR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18
• any elective indication of colonoscopy

You may not qualify if:

• having visual impairments,
• having dementia
• limited Danish language skills
• a high tendency to travel sickness
• having skin disease in the facial area
• having epilepsy

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Department of Gastroenterology, Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38851457 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahdi Shamali, PhD

  Herlev and Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

• Hanne Konradsen, PhD

  Herlev and Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc Researcher

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 13, 2023
• Study Start: March 22, 2023
• Primary Completion: June 14, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)