NCT06446518

Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery

A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain. Participants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status. Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.

Conditions

• Pectus Excavatum
• Pectus Deformity

Interventions

Type	Name	Description
DEVICE	Virtual reality exposure	Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2024-06-06
• Last updated: 2025-09-08

Locations

1 site across 1 country: Hungary