The Effect of Virtual Reality Distraction on Pain During Colonoscopy

To Evaluate the Effect of Virtual Reality Application in Reducing Patients' Pain, Nervousness, iv Analgesics Dosage and Improve Patient Satisfaction During Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Valid MeSH Conditions
• Intervention / Treatment: Other: VRD

Detailed Description

Colonoscopy is one of the endoscopic procedures used for the diagnostic and interventional procedures of the intestines. Colonoscopy can often cause pain associated with embarrassment, anxiety, and physical and emotional discomfort. The fear of experiencing pain during colonoscopy can cause the patient refusal to undergo the examination, with possible negative implications on both diagnosis and treatment. Several studies showed that fear of being embarrassed or fear of pain during colonoscopy were positively associated with unwillingness to participate in colorectal cancer screening. Sedative and narcotic medications used during colonoscopy can cause nausea/vomiting, absence from work, impaired cognitive function and need for an escort home. These factors are often cited as reasons patients delay or avoid colonoscopy. Moreover, sedation increases complications associated with colonoscopy and has potential risks such as hypoxemia, hypoventilation, aspiration pneumonia and myocardial infarction. Unsedated colonoscopy is not widely accepted and inferior in quality to sedated examination. This highlights the need for non pharmacological anxiolysis and analgesia during colonoscopy. The use of sedoanalgesia by administering iv drugs for lower gastrointestinal endoscopic procedures is strongly recommended by several guidelines. If no sedation is offered, the patient must accept a higher chance of unacceptable discomfort and the endoscopist a lower chance of completing the procedure because of patient discomfort. Based on data from previous studies conflicting results, currently available data do not support the use of acupuncture as an analgesic adjuvant during colonoscopy. Listening relaxing music during pain invoking experience is considered to have therapeutic effect, as it promotes relaxing responses, triggers positive associations, and diverts attention from anxiety. A prospective randomized controlled trial to test the hypotheses that visual distractions could reduce the requirement for sedatives during colonoscopy, and that the combination of audio and visual distractions could have additive beneficial effects. Virtual reality (VR), the technology consisting of a visual system, an audio system, and an integrated setup, has emerged as a promising tool for the management of pain and anxiety in various clinical settings. By stimulating multiple human senses, VR systems can provide users with an immersive experience and a feeling of presence in the virtual world. VR exposure can markedly reduce anxiety and persistent pain intensity, accelerated wound healing, and enhanced neurorehabilitation outcomes in patients with burns and complex regional pain syndrome. However, few studies have analysed the effect of VR exposure on patient pain and anxiety before invasive endoscopic procedures, even though many studies have suggested that VR exposure has anxiolytic effects and reduces stress. This study aims to evaluate the effect of virtual reality applications during a colonoscopy on the pain experienced by patients.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Saket
    • New Delhi, Saket, India, 110017
      • Max Institute of Medical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. hearing and visual disorders;
2. psychiatric illnesses;
3. chronic pain disorders;
4. Alzheimer's disease or other dementia disorders;
5. a history of taking psychoactive drugs;
6. a history of taking beta blockers and Buscopan.
7. any contraindication including allergy to either midazolam or fentanyl.
8. those who opt for general anaesthesia.
9. Epilepsy
10. Balance disorders
11. Claustrophobia -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy with VRD	Other: VRD; Virtual Reality Application
Placebo Comparator: colonoscopy without VRD	Other: VRD; Virtual Reality Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of virtual reality distraction in patient's anxiety and nervousness during colonoscopy.	Patient anxiety and nervousness score is calculated using STAI questionnaire (State Trait Anxiety inventory: range from 20-80, higher scores indicate greater anxiety). STAI trait questionnaire is provided before colonoscopy. STAI state questionnaire is provided after colonoscopy.	30 min after colonoscopy, Post procedural
To evaluate the effect of virtual reality distraction in patient's sedative dosage during colonoscopy.	Requirement of additional IV sedatives and analgesics dosage (dosage of Midazolam in mg and Fentanyl in mcg) will be noted during colonoscopy.	Periprocedural, 30- 40 minutes
To evaluate the effect of virtual reality distraction in patient's discomfort during colonoscopy.	Patient discomfort during colonoscopy will be measured using a five-point Modified Gloucester Comfort scale; 1: no discomfort and 5: severe discomfort	Periprocedural, 30 - 40 minutes
To evaluate the effect of virtual reality distraction in patient's satisfaction during colonoscopy.	Patient satisfaction scale for the procedure will be recorded 30 min after the procedure in the recovery room. Patient satisfaction scale of 1 to 5 is recorded after the colonoscopy; 1: extremely dissatisfied, 5: extremely satisfied.	30 min after colonoscopy, Post procedural
To evaluate the effect of virtual reality distraction during colonoscopy in patient's willingness to return for colonoscopy	Patient's willingness to return for the procedure will be recorded 30 min after the procedure in the recovery room. Willingness to return for the procedure in a scale of 1 to 5; 1 : not at all willing, 5: willing.	30 min after colonoscopy, Post procedural

Collaborators and Investigators

• Sponsor: Max Healthcare Insititute Limited
• Investigators: Principal Investigator: Vivek Raj, MD, FRCP, Principal Director and HOD, Gastroenterology and Hepatology Max Super-specialty Hospital, New Delhi.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MIME/DNB/SKT-2023-0970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No