Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery

Not Applicable

Recruiting

• Conditions: Pectus Excavatum; Pectus Deformity
• Interventions: Device: Virtual reality exposure

• Registration Number: NCT06446518
• Lead Sponsor: Semmelweis University

Brief Summary

The goal of this clinical trial is to test virtual reality in adolescents undergoing minimally invasive repair of pectus excavatum surgery. The main questions it aims to answer are:

* Can virtual reality decrease anxiety in adolescents on the day of the surgery?

* Can virtual reality be used as a pain modulator in adolescents in postoperative care? Participants will be asked to wear a VR headset for a minimum of 1 hour before and after the surgery. Patients will be asked to fill out three anxiety tests: on admission, in the operating room and on the surgical ward on the day after surgery.

Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-17
• Status Verified: 2024-05
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Last Update Submitted: 2024-05-31
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR intervention group	Virtual reality exposure	On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission. Patients are asked to use the VR headset a minimum of 1 hour before surgery. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Patients are encouraged to use the VR headset after surgery, any time when they feel comfortable. Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery.

Primary Outcome Measures

Name	Time	Method
Decrease in anxiety	1-2 days	Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.

Secondary Outcome Measures

Name	Time	Method
Decrease in pain	1-2 days	Pain assessed by Numerical Pain Rating Scale level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)

Trial Locations

Locations (1)

Department of Paediatrics, Semmelweis University; 🇭🇺 Budapest, Hungary