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AzTrials

Valid MeSH ConditionsNCT07496333

The Effect of Virtual Reality Distraction on Pain During Colonoscopy

A study testing VRD in people with Valid MeSH Conditions, run by Max Healthcare Insititute Limited at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Valid MeSH Conditions
What is being tested?
VRD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteIndia
Study dates
3 Oct 2023to 2 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 11Show fewer
  • any contraindication including allergy to either midazolam or fentanyl.
  • those who opt for general anaesthesia.
  • Epilepsy
  • Balance disorders
  • Claustrophobia -

Trial locations and contacts

1 site in 1 country.

India1 site
  • Max Institute of Medical Education

    New Delhi, Saket, 110017

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
VRD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRDOther

    Virtual Reality Application

Study groups in NCT07496333
Study groupRoleWhat they receive
Colonoscopy with VRDExperimentalNot described
Receives: Other: VRD
colonoscopy without VRDPlacebo comparatorNot described
Receives: Other: VRD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 min after colonoscopy, Post procedural

Secondary outcomes (5)
  1. 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.

    Measured: 30 min after colonoscopy, Post procedural

  2. 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.

    Measured: Periprocedural, 30- 40 minutes

  3. 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

    Measured: Periprocedural, 30 - 40 minutes

  4. 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.

    Measured: 30 min after colonoscopy, Post procedural

  5. 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.

    Measured: 30 min after colonoscopy, Post procedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start3 Oct 2023
  3. Primary completion2 Oct 2024
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Virtual reality Display
Masking
Single blind
Who is masked
Care provider
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496333
Sponsor's protocol ID
MIME/DNB/SKT-2023-0970
Status last verified
Mar 2026
First submitted
23 Jan 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 8946975

Questions about this trial

What is this clinical trial studying?

A study testing VRD in people with Valid MeSH Conditions, run by Max Healthcare Insititute Limited at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effect of Virtual reality distraction on pain during colonoscopy (time frame: 30 min after colonoscopy, Post procedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07496333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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