NCT05701566

Brief Summary

A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 10, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 18, 2023

Last Update Submit

April 6, 2023

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.

    Questionnaire (1 - not satisfied at all, 5 - very satisfied)

    1 day

Secondary Outcomes (6)

  • Pain during the procedure

    1 day

  • polyp detection rate (PDR)

    during colonoscopy procedure

  • Colonoscopy duration

    during colonoscopy procedure

  • Post colonoscopy adverse events

    1 day

  • Time-to-return to daily activities (work, driving)

    1 day

  • +1 more secondary outcomes

Study Arms (2)

virtual reality group

EXPERIMENTAL

unsedated colonoscopy using virtual reality headset.

Device: virtual reality headset

colonoscopy with standard sedation

ACTIVE COMPARATOR

standard sedated colonoscopy.

Other: colonoscopy with standard sedation.

Interventions

virtual reality headsetDEVICE

use of virtual reality headset during colonoscopy as a substitute to sedation.

virtual reality group
colonoscopy with standard sedation.OTHER

use of standard sedation during colonoscopy.

colonoscopy with standard sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (≥18) with any elective indication for colonoscopy.

You may not qualify if:

  • known seizures' disorders, cognitive, visual or auditory impairment.
  • patients who were unable or unwilling to sign an informed consent.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology department, Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ido Veisman, Dr.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ido Veisman, Dr.

CONTACT

+97235307072Ido.Veisman@sheba.health.gov.il

Revital Dvir, Mrs.

CONTACT

+97235307072revital.dvir@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: pilot randomized controled study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

June 1, 2022

Primary Completion

February 1, 2023

Study Completion

December 1, 2023

Last Updated

April 10, 2023

Record last verified: 2023-01

Locations

IL(1)