The Effect of Virtual Reality Distraction on Pain During Colonoscopy

Max Healthcare

Status: Completed

Conditions: Valid MeSH Conditions

Treatments: Other: VRD

Study type: Interventional

Funder types: Other

Identifiers

NCT07496333

MIME/DNB/SKT-2023-0970

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups, including a placebo group

Colonoscopy with VRD

Experimental group

Treatment:

Other: VRD

colonoscopy without VRD

Placebo Comparator group

Treatment:

Other: VRD