Skip to main content
OpenTrials
Completed

NCT Number: NCT06446518

Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Pectus Deformity

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paediatric Centre, Semmelweis University

Budapest, 1083, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Exposure

Device

Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.

Primary outcomes

  1. Change in anxiety

    Time frame: 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 outcomes

  1. Change in pain and vital parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Új Nemzeti Kiválóság Program

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.