Virtual Reality Mindfulness in Preoperative Anxious Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedNovember 21, 2023
November 1, 2023
11 months
April 26, 2023
November 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Virtual Reality
EXPERIMENTALEach patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes.
Interventions
Application used to realize mindfulness in virtual reality
Use of this virtual reality headset to deliver a single mindfulness session
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Epilepsy
- Pacemaker wearers
- Mental diseases
- Alcohol or drug addiction
- Severe hearing loss or blindness
- Simultaneous participation to other studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea Polito
Mendrisio, 6850, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Polito
Ospedale Beata Vergine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesia Clinical Professor, Principal Investigator
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 16, 2023
Study Start
June 15, 2023
Primary Completion
May 1, 2024
Study Completion
June 1, 2024
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share