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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard pre-procedural education for cardiac catheterization. | |
| Treatment | Experimental | Standard pre-procedural education plus virtual reality experience for cardiac catheterization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality experience | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
There are no plans to share data at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard preprocedural education |
| FG001 | VR Group (Treatment) | Stanard preprocedural education plus viewing of virtual reality video |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients undergoing clinical cardiac catheterization, who voluntarily agreed to study participation
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard preprocedural education |
| BG001 | VR Group (Treatment) | Standard preprocedural education plus viewing of virtual reality video |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Mean STAI score | Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure. |
|
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.
Monitored VR patients for headache, nausea, dizziness, fatigue, and visual disturbances. Assessments occurred pre-VR viewing, immediate post VR viewing, and 24 hours post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard pre-procedural education for cardiac catheterization. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Madder | Spectrum Health | 6163916660 | stephen.orey@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2021 | Jul 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Treatment | Standard pre-procedural education plus virtual reality experience for cardiac catheterization. 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)
| 0 | 89 | 0 | 89 | 0 | 89 |
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