Preprocedure AnxietyVR-THEIANCT03662607

Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA

A study testing Virtual reality experience in people with Preprocedure Anxiety, run by Corewell Health West at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Preprocedure Anxiety
What is being tested?: Virtual reality experience
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2017to 31 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
18-75 years of age
Signed study consent form

Who cannot join

History of cardiac procedure(s) in a cardiac catheterization laboratory
History of seizures, migraine headaches or severe susceptibility to motion sickness
Currently taking psychotropic drugs or on long-term psychotropic treatment
Unable to read and speak English
Visually impaired
Unable to provide written consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Spectrum Health
Grand Rapids, Michigan, 49503

Other trials in United States

About this study

The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.

Conditions: Preprocedure Anxiety
Being tested: Virtual reality experience
Keywords: preprocedure, anxiety, cardiac catheterization
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 reality experienceBehavioural
- Baseline wellness self-assessment administered (reporting on absence or presence and degree of severity of headache, nausea, dizziness, fatigue and vision abnormalities)
- Seated comfortably and free of direct obstruction
- Shown individual components of the VR system (View-Master with smartphone; headphones); given instructions; encouraged to ask questions.
- Begin the VR experience. Study personnel stay in the room \& provide guidance and answer questions regarding the technology
- When VR experience concluded, wellness self-assessment will be administered again.

Study groups in NCT03662607
Study group	Role	What they receive
Control	No intervention	Standard pre-procedural education for cardiac catheterization.
Treatment	Experimental	Standard pre-procedural education plus virtual reality experience for cardiac catheterization. Receives: Behavioral: Virtual reality experience

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)
The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201731 Dec 2025

First posted7 Sep 2018
Study start18 Apr 2017
Primary completion29 Nov 2021
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preprocedure 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03662607
Sponsor's protocol ID: 2017-074
Acronym: VR-THEIA
Status last verified: Apr 2026
First submitted: 27 Sep 2017
Last updated: 14 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There are no plans to share data at this time.

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
ClinicalTrials.gov ID: NCT03662607
Acronym / sponsor ID: VR-THEIA / 2017-074
Conditions: Preprocedure Anxiety
Keywords: preprocedure, anxiety, cardiac catheterization
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Corewell Health WestUniversity, hospital or other
Study start: 18 Apr 2017 (actual)
Primary completion: 29 Nov 2021 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 7 Sep 2018 (actual)
Results: Posted 11 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Standard pre-procedural education for cardiac catheterization.
Treatment	Experimental	Behavioral: Virtual reality experienceStandard pre-procedural education plus virtual reality experience for cardiac catheterization.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
18-75 years of age
Signed study consent form

Key exclusion criteria (6 listed)

History of cardiac procedure(s) in a cardiac catheterization laboratory
History of seizures, migraine headaches or severe susceptibility to motion sickness
Currently taking psychotropic drugs or on long-term psychotropic treatment
Unable to read and speak English
Visually impaired

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 reality experience* Baseline wellness self-assessment administered (reporting on absence or presence and degree of severity of headache, nausea, dizziness, fatigue and vision abnormalities) * Seated comfortably and free of direct obstruction * Shown individual components of the VR system (View-Master with smartphone; headphones); given instructions; encouraged to ask questions. * Begin the VR experience. Study personnel stay in the room \& provide guidance and answer questions regarding the technology * When VR experience concluded, wellness self-assessment will be administered again.	Behavioural	Treatment

Primary outcome

Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)
Time frame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Results and safety

Results posted to the registry on 11 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	91	91
VR Group (Treatment)	89	89

Primary outcome: Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)

Time frame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.. Mean (Standard Deviation). Unit: Mean STAI score

Measure	Control n = 91	VR Group (Treatment) n = 89
Value	69.81 (17.11)	65.71 (15.22)

Adverse events

Time frame: Per patient assigned to the VR arm, baseline assessment was conducted immediately prior to watching the video. The patient was than assessed with the same questionnaire immediately after watching the video. The third and final assessment was conducted 24 hours after watching the video. Therefore, the time frame over which adverse event data were collected was 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 91 (0%)	0 of 91 (0%)	0 of 91
Treatment	0 of 89 (0%)	0 of 89 (0%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There are no plans to share data at this time.

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.

The record lists no contact. Use the official record to reach the sponsor.

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 experience in people with Preprocedure Anxiety, run by Corewell Health West at 1 site in United States.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Apr 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI) (time frame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662607.

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 14 Apr 2026.