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

Pectus Excavatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446518
• Other study ID #: NRG 2022/2
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pain, Postoperative
• Pectus Deformity
• Pectus Excavatum

Intervention

Device:
• Virtual reality exposure
Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.

Locations

Country	Name	City	State
Hungary	Department of Paediatrics, Semmelweis University	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University	Új Nemzeti Kiválóság Program

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in anxiety	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.	1-2 days
Secondary	Decrease in pain	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)	1-2 days