Virtual Reality Mindfulness in Preoperative Anxious Patients

Anxiety State Clinical Trial

Official title:

Virtual Reality Mindfulness in Preoperative Anxious Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860192
• Other study ID #: APolito1
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Ospedale Regionale di Mendrisio
• Contact: Andrea Polito
• Phone: 0918113510
• Email: andrea.polito[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this interventional study is to reduce preoperative anxiety by Virtual Reality mindfulness.

Population: all adults, able to give their consent and scheduled for surgery with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) score > 10. The study will recruit 100 patients in one university teaching hospital.

The main question it aims to answer is: may mindfulness by Virtual Reality reduce preoperative anxiety in patients particularly anxious for the surgery? Participants will be asked to undergo to a single mindfulness virtual reality session before the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults able to give their consent, scheduled for elective surgery and with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) > 10

Exclusion Criteria:

• Pregnancy

• Epilepsy

• Pacemaker wearers

• Mental diseases

• Alcohol or drug addiction

• Severe hearing loss or blindness

• Simultaneous participation to other studies

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Preoperative Period
• Test Anxiety

Intervention

Device:
• Virtual Reality
Use of this virtual reality headset to deliver a single mindfulness session

Other:
• application for mindfulness
Application used to realize mindfulness in virtual reality

Locations

Country	Name	City	State
Switzerland	Andrea Polito	Mendrisio

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Regionale di Mendrisio

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from one week before surgery in anxiety on STAI score some hours before the intervention	The State-Trait Anxiety Inventory (STAI) score is a validated, self reported instrument to assessing state and trait anxiety. Possible scores range from "no or low anxiety" (20-37) to "high anxiety" (45-80). Change = (one week before - some hours before the surgery and after mindfulness in virtual reality)	Up to two weeks