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NOT YET RECRUITING
NCT07911436
NA

Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate whether using a Virtual Reality (VR) headset can help young people relax during the placement of an epidural catheter for pain control after pectus surgery. An epidural catheter is a thin tube that is inserted by the anesthesiologist between two vertebrae in the back. Many teenagers experience anxiety or stress during the placement of this catheter. To help reduce anxiety, medication called Midazolam can be given through an IV line. However, this does not always provide enough relief. Scientific studies have shown that virtual reality (VR) can help reduce anxiety, stress, and pain during medical procedures. By focusing on a virtual environment, patients are less aware of the procedure itself. In particular, VR has been shown to be a safe and effective way of improving comfort for children and adolescents during medical examinations and treatments. A total of 78 adolescents aged 13 to 19 years will participate in this study. Participants will be randomly assigned to one of two groups, each consisting of 39 participants: Children in the interventional group will wear a VR headset during the placement of the epidural catheter. If the child still experiences significant anxiety or stress during the procedure, Midazolam will be administered through the IV line. Children assigned to the control group will receive the usual care. This means that Midazolam will be given through the IV line if your child experiences significant anxiety or stress. Children in this group will not receive a VR headset.

Official title: Efficacy of Virtual Reality Distraction on Procedural Anxiety in Adolescents Undergoing Epidural Placement for Pectus Surgery: An Open-Label Prospective Randomized Controlled Trial.

Key Details

Gender

All

Age Range

13 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-11-01

Completion Date

2028-08-31

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DEVICE

VR- headset

Children will wear a VR headset during the placement of the epidural catheter.