NCT07496333

Brief Summary

Colonoscopy is a primary method of examining colorectal diseases. However, the procedure is associated with embarrassment, pain, and discomfort. This make patients less willing to be subjected to repeat surveillance colonoscopies. Performing colonoscopy under sedation is widely used in clinical practice. However, sedation increases complications associated with colonoscopy and has potential risks such as hypoxemia, hypoventilation, aspiration pneumonia. Therefore, several studies have examined non-pharmacological interventions to reduce anxiety and pain during endoscopy. These studies found that combined visual and auditory distraction is better at reducing discomfort than auditory distraction alone. Virtual reality is a method of displaying computer images in order to isolate the individual from real life for a while. The virtual reality application is considered an effective tool for distraction during pain and there are various studies showing its effectiveness in the management of pain and anxiety in various clinical settings. There are limited studies showing effectiveness of virtual reality application in colonoscopy and no studies have been done in India about the same. The aim of this study is to evaluate the effect of virtual reality applications during a colonoscopy on the pain experienced by patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

October 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

January 23, 2026

Last Update Submit

March 23, 2026

Conditions

Valid MeSH Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of Virtual reality distraction on pain during colonoscopy

    Primary outcome of this study is patient's pain score which is recorded after the colonoscopy procedure (post procedural) once completely recovered from sedation. The pain intensity is recorded according to Visual analog scale (VAS) in a scale of 0-10. 0- being no pain and 10 being maximum pain.

    30 min after colonoscopy, Post procedural

Secondary Outcomes (5)

  • To evaluate the effect of virtual reality distraction in patient's anxiety and nervousness during colonoscopy.

    30 min after colonoscopy, Post procedural

  • To evaluate the effect of virtual reality distraction in patient's sedative dosage during colonoscopy.

    Periprocedural, 30- 40 minutes

  • To evaluate the effect of virtual reality distraction in patient's discomfort during colonoscopy.

    Periprocedural, 30 - 40 minutes

  • To evaluate the effect of virtual reality distraction in patient's satisfaction during colonoscopy.

    30 min after colonoscopy, Post procedural

  • To evaluate the effect of virtual reality distraction during colonoscopy in patient's willingness to return for colonoscopy

    30 min after colonoscopy, Post procedural

Study Arms (2)

Colonoscopy with VRD

EXPERIMENTAL
Other: VRD

colonoscopy without VRD

PLACEBO COMPARATOR
Other: VRD

Interventions

VRDOTHER

Virtual Reality Application

Colonoscopy with VRDcolonoscopy without VRD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 to 80 years;
  • absence of any history of overt or borderline psychiatric disorders;
  • abstinence from psychoactive medications. -

You may not qualify if:

  • hearing and visual disorders;
  • psychiatric illnesses;
  • chronic pain disorders;
  • Alzheimer's disease or other dementia disorders;
  • a history of taking psychoactive drugs;
  • a history of taking beta blockers and Buscopan.
  • any contraindication including allergy to either midazolam or fentanyl.
  • those who opt for general anaesthesia.
  • Epilepsy
  • Balance disorders
  • Claustrophobia -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Institute of Medical Education

New Delhi, Saket, 110017, India

Location

Related Publications (1)

  • Mahajan RJ, Agrawal S, Barthel JS, Marshall JB. Are patients who undergo open-access endoscopy more anxious about their procedures than patients referred from the GI clinic? Am J Gastroenterol. 1996 Dec;91(12):2505-8.

    PMID: 8946975BACKGROUND

Study Officials

  • Vivek Raj, MD, FRCP

    Principal Director and HOD, Gastroenterology and Hepatology Max Super-specialty Hospital, New Delhi.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Endoscopist are masked from the allocation of groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Virtual reality Display
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

March 27, 2026

Study Start

October 3, 2023

Primary Completion

October 2, 2024

Study Completion

October 2, 2024

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)