Test AnxietyNCT05860192
Virtual Reality Mindfulness in Preoperative Anxious Patients
A study testing Virtual Reality and application for mindfulness in people with Test Anxiety and Anxiety State, run by Ospedale Regionale di Mendrisio at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Test Anxiety, Anxiety State, Preoperative Period
- What is being tested?
- Virtual Reality and application for mindfulness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Epilepsy
- Pacemaker wearers
- Mental diseases
- Alcohol or drug addiction
- Severe hearing loss or blindness
- Simultaneous participation to other studies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Andrea Polito
Mendrisio, 6850
Andrea Polito, 0918113510, andrea.polito@eoc.ch
About this study
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.
- Conditions
- Test Anxiety, Anxiety State, Preoperative Period
- Being tested
- Virtual Reality, application for mindfulness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Meta, Oculus 2
Use of this virtual reality headset to deliver a single mindfulness session
application for mindfulnessOther
Also called Guided Meditation VR
Application used to realize mindfulness in virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Each patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes. Receives: Device: Virtual Reality; Other: application for mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jun 2023
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Mendrisio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Polito, Ospedale Regionale di Mendrisio
- Investigators
- Andrea Polito, Principal investigator, Ospedale Beata Vergine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860192
- Sponsor's protocol ID
- APolito1
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mindfulness in Preoperative Anxious Patients
- ClinicalTrials.gov ID
- NCT05860192
- Acronym / sponsor ID
- APolito1
- Conditions
- Test Anxiety, Anxiety State, Preoperative Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale Regionale di MendrisioUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual Reality, Other: application for mindfulnessEach patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Epilepsy
- Pacemaker wearers
- Mental diseases
- Alcohol or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: Meta, Oculus 2Use of this virtual reality headset to deliver a single mindfulness session | Device | Virtual Reality |
| application for mindfulnessAlso: Guided Meditation VRApplication used to realize mindfulness in virtual reality | Other | Virtual Reality |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Polito principal investigator
Ospedale Beata Vergine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and application for mindfulness in people with Test Anxiety and Anxiety State, run by Ospedale Regionale di Mendrisio at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Polito (0918113510, andrea.polito@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from one week before surgery in anxiety on STAI score some hours before the intervention (time frame: Up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.