Using virtual reality to reduce anxiety and pain in teens during pectus surgery
A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
This study is testing if using virtual reality can help reduce anxiety and pain for teens having surgery to fix a sunken chest.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT06446518 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of virtual reality (VR) in reducing anxiety and modulating pain in adolescents undergoing minimally invasive repair of pectus excavatum surgery. Participants aged 14-18 will wear a VR headset for at least one hour before and after their surgery. The study will compare the anxiety and pain levels of those using VR to a control group that does not use VR, with assessments conducted at various points during their hospital stay. The goal is to determine if VR can serve as a beneficial tool in the perioperative setting for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 14-18 with pectus excavatum or carinatum undergoing MIRPE surgery.
Not a fit: Patients with cognitive impairments, severe vision loss, or those unable to wear a VR headset due to head deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the surgical experience by reducing anxiety and postoperative pain in adolescents.
How similar studies have performed: While the use of virtual reality in medical settings is gaining traction, this specific application for perioperative anxiety and pain modulation in adolescents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient between 14-18 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
Where this trial is running
Budapest
- Department of Paediatrics, Semmelweis University — Budapest, Hungary (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.