Virtual Reality Mindfulness in Preoperative Anxious Patients
Primary Purpose
Test Anxiety, Anxiety State, Preoperative Period
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual Reality
application for mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Test Anxiety
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 Epilepsy Pacemaker wearers Mental diseases Alcohol or drug addiction Severe hearing loss or blindness Simultaneous participation to other studies
Sites / Locations
- Andrea Polito
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05860192
First Posted
April 26, 2023
Last Updated
May 5, 2023
Sponsor
Ospedale Regionale di Mendrisio
1. Study Identification
Unique Protocol Identification Number
NCT05860192
Brief Title
Virtual Reality Mindfulness in Preoperative Anxious Patients
Official Title
Virtual Reality Mindfulness in Preoperative Anxious Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Regionale di Mendrisio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Test Anxiety, Anxiety State, Preoperative Period
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Meta, Oculus 2
Intervention Description
Use of this virtual reality headset to deliver a single mindfulness session
Intervention Type
Other
Intervention Name(s)
application for mindfulness
Other Intervention Name(s)
Guided Meditation VR
Intervention Description
Application used to realize mindfulness in virtual reality
Primary Outcome Measure Information:
Title
Change from one week before surgery in anxiety on STAI score some hours before the intervention
Description
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)
Time Frame
Up to two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Epilepsy
Pacemaker wearers
Mental diseases
Alcohol or drug addiction
Severe hearing loss or blindness
Simultaneous participation to other studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Polito
Phone
0918113510
Email
andrea.polito@eoc.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Polito
Organizational Affiliation
Ospedale Beata Vergine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrea Polito
City
Mendrisio
ZIP/Postal Code
6850
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Mindfulness in Preoperative Anxious Patients
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