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Clinical Trials/NCT05860192
NCT05860192
Recruiting
Not Applicable

Virtual Reality Mindfulness in Preoperative Anxious Patients

Ospedale Regionale di Mendrisio1 site in 1 country100 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Test Anxiety
Sponsor
Ospedale Regionale di Mendrisio
Enrollment
100
Locations
1
Primary Endpoint
Change from one week before surgery in anxiety on STAI score some hours before the intervention
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ospedale Regionale di Mendrisio
Responsible Party
Principal Investigator
Principal Investigator

Andrea Polito

Anesthesia Clinical Professor, Principal Investigator

Ospedale Regionale di Mendrisio

Eligibility Criteria

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
  • Pacemaker wearers
  • Mental diseases
  • Alcohol or drug addiction
  • Severe hearing loss or blindness
  • Simultaneous participation to other studies

Outcomes

Primary Outcomes

Change from one week before surgery in anxiety on STAI score some hours before the intervention

Time Frame: 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)

Study Sites (1)

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