Virtual Reality Mindfulness in Preoperative Anxious Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change from one week before surgery in anxiety on STAI score some hours before the intervention
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Polito
Anesthesia Clinical Professor, Principal Investigator
Ospedale Regionale di Mendrisio