Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery

Semmelweis University

Status: Completed

Conditions: Pectus Deformity; Pectus Excavatum

Treatments: Device: Virtual reality exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT06446518

NRG 2022/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

VR intervention group

Experimental group

Description:

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.

Treatment:

Device: Virtual reality exposure

Control group

No Intervention group

Description:

On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission. 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. 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.