Preprocedure Anxiety
Conditions
Keywords
preprocedure, anxiety, cardiac catheterization
Brief summary
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center * 18-75 years of age * Signed study consent form
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard preprocedural education | 91 |
| VR Group (Treatment) Standard preprocedural education plus viewing of virtual reality video | 89 |
| Total | 180 |
Baseline characteristics
| Characteristic | VR Group (Treatment) | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 92 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 88 Participants | 46 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 8.52 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 89 Participants | 180 Participants | 91 Participants |
| Sex: Female, Male Female | 35 Participants | 65 Participants | 30 Participants |
| Sex: Female, Male Male | 54 Participants | 115 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 89 |
| other Total, other adverse events | 0 / 91 | 0 / 89 |
| serious Total, serious adverse events | 0 / 91 | 0 / 89 |
Outcome results
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.
Time frame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI) | 69.81 Mean STAI score | Standard Deviation 17.11 |
| VR Group (Treatment) | Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI) | 65.71 Mean STAI score | Standard Deviation 15.22 |