Virtual Reality Mindfulness in Preoperative Anxious Patients

Not Applicable

Recruiting

• Conditions: Anxiety State; Test Anxiety; Preoperative Period
• Interventions: Device: Virtual Reality; Other: application for mindfulness

• Registration Number: NCT05860192
• Lead Sponsor: Ospedale Regionale di Mendrisio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-06-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	Each patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes.
Virtual Reality	application for mindfulness	Each patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes.

Primary Outcome Measures

Name	Time	Method
Change from one week before surgery in anxiety on STAI score some hours before the intervention	Up to two weeks	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)

Trial Locations

Locations (1)

Andrea Polito; 🇨🇭 Mendrisio, Switzerland