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.
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.
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.
- Conditions
- Valid MeSH Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Colonoscopy with VRD | Experimental | Not described Receives: Other: VRD |
| colonoscopy without VRD | Placebo comparator | Not described Receives: Other: VRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted27 Mar 2026
- Study start3 Oct 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valid MeSH ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivek Raj, MD, FRCP, Principal investigator, Principal Director and HOD, Gastroenterology and Hepatology Max Super-specialty Hospital, New Delhi.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Virtual Reality Application in Reducing Patients' Pain, Nervousness, iv Analgesics Dosage and Improve Patient Satisfaction During Colonoscopy
- ClinicalTrials.gov ID
- NCT07496333
- Acronym / sponsor ID
- MIME/DNB/SKT-2023-0970
- Conditions
- Valid MeSH Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Virtual reality Display
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with VRD | Experimental | Other: VRD |
| colonoscopy without VRD | Placebo comparator | Other: VRD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 to 80 years;
- absence of any history of overt or borderline psychiatric disorders;
- abstinence from psychoactive medications. -
Key exclusion criteria (11 listed)
- hearing and visual disorders;
- psychiatric illnesses;
- chronic pain disorders;
- Alzheimer's disease or other dementia disorders;
- a history of taking psychoactive drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRDVirtual Reality Application | Other | Colonoscopy with VRD, colonoscopy without VRD |
Primary outcome
To evaluate the effect of Virtual reality distraction on pain during colonoscopy
Time frame: 30 min after colonoscopy, Post procedural
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.
5 secondary outcomes
To evaluate the effect of virtual reality distraction in patient's anxiety and nervousness during colonoscopy.
Time frame: 30 min after colonoscopy, Post procedural
To evaluate the effect of virtual reality distraction in patient's sedative dosage during colonoscopy.
Time frame: Periprocedural, 30- 40 minutes
To evaluate the effect of virtual reality distraction in patient's discomfort during colonoscopy.
Time frame: Periprocedural, 30 - 40 minutes
To evaluate the effect of virtual reality distraction in patient's satisfaction during colonoscopy.
Time frame: 30 min after colonoscopy, Post procedural
To evaluate the effect of virtual reality distraction during colonoscopy in patient's willingness to return for colonoscopy
Time frame: 30 min after colonoscopy, Post procedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 8946975Mahajan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Raj, MD, FRCP principal investigator
Principal Director and HOD, Gastroenterology and Hepatology Max Super-specialty Hospital, New Delhi.
1 site in 1 country: see every site and its status.
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.