Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery

Not Applicable

Completed

• Conditions: Pectus Excavatum; Pectus Deformity

• Registration Number: NCT06446518
• Lead Sponsor: Semmelweis University

Brief 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.

Study Timeline

• Study Start: 2022-08-17
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-08-31
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change 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
Change in pain and vital parameters	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).; Vital parameters that are monitored during the study are blood pressure, heart rate, peripheral oxygen saturation and respiratory rate.; Pain will also be followed with analgesic demand per patien during the first postoperative day.

Trial Locations

Locations (1)

Paediatric Centre, Semmelweis University; 🇭🇺 Budapest, Budapest, Hungary