Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery (NCT06446518) | Clinical Trial Compass
CompletedNot Applicable
Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery
Hungary50 participantsStarted 2022-08-17
Plain-language summary
In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.
Who can participate
Age range
13 Years – 18 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:
* Patient between 13-18 years old
* reported chest deformity (pectus excavatum/ carinatum)
* patients undergoing MIRPE surgery in general anesthesia
* Hungarian fluency
* willing to comply with study procedures.
Exclusion Criteria:
* gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
* Head injury
* Head infection
* Altered mental status (independently from midazolam)
* Scabies or louse
* Dizziness or vertigo
* Blindness or severe vision loss
* Lack of parental/ guardian or patient consent
* Those, who has a head deformity, so VR headset does not fit well
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.