Virtual Reality Mindfulness in Preoperative Anxious Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05860192

Enrollment

100

Registered

2023-05-16

Start date

2023-06-15

Completion date

2024-06-30

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Preoperative Period, Test Anxiety

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.

Interventions

DEVICEVirtual Reality

Use of this virtual reality headset to deliver a single mindfulness session

OTHERapplication for mindfulness

Application used to realize mindfulness in virtual reality

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Switzerland

Contacts

Primary ContactAndrea Polito

andrea.polito@eoc.ch0918113510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026