CompletedNot Applicable

Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Patients Undergoing Colonoscopy

Palestinian Territories150 participantsStarted 2024-09-10

Plain-language summary

The goal of this randomized controlled trial was to investigate the effect of Virtual Reality (VR) on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy. The study aimed to determine the efficacy of VR as a non-pharmacological intervention to improve the patient experience during the procedure. The main research hypotheses are: H01: There will be no significant difference in anxiety levels between patients who receive immersive VR during colonoscopy and those who receive standard care. H02: There will be no significant difference in perceived stress levels between patients who receive immersive VR during colonoscopy and those who receive standard care. H03: There will be no significant difference in pain levels between patients who receive immersive VR during colonoscopy and those who receive standard care. H04: There will be no significant difference in satisfaction levels between patients who receive immersive VR during colonoscopy and those who receive standard care. Participants will: Receive either a VR intervention or standard care during their colonoscopy. Wear a VR headset for 15-30 minutes, immersing themselves in a natural environment with relaxing music and nature sounds. Complete assessments of anxiety, stress, pain, and satisfaction before and after the procedure using validated questionnaires.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients scheduled for elective colonoscopy * Patients older than 18 years * Patients with no history of previous colonoscopy procedures * Patients experiencing moderate to severe anxiety and stress Exclusion Criteria: * Patients who have a history of psychiatric disorders, epilepsy, hypertension, or chronic pain. * Patients who are mute and could not read, or write, patients with visual, hearing, or cognitive impairment. * Patients who implanted hearing aids or cardiac pacemakers. * Patients who were given any anxiolytic, sedative, or hypnotic drugs before or during procedure. * Patients who were exposed to complications during the operation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

State-Trait Anxiety Inventory (STAI)

Timeframe: before colonoscopy and then 60 minutes post-procedure

Perceived Stress Scale (PSS-10)

Timeframe: before colonoscopy and then 60 minutes post-procedure

Trial details

NCT IDNCT07145203

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Anxiety trials