VITALISE: Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Study Details
Study Description
Brief Summary
The purpose of this pilot trial is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
In an open-label pilot trial, women will undergo a single session using the virtual reality biofeedback program. The objective of this study is to assess feasibility and acceptability of virtual reality biofeedback program in postpartum women with specific assessments of anxiety and depression outcomes.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Virtual Reality Session All participants in this study will complete a 1 hour virtual reality session. |
Device: Flowly (TMC-CP01)
The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.
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Outcome Measures
Primary Outcome Measures
- Post-Session Feasibility and Acceptability [Completed immediately after the VR session.]
Patient questionnaire on their satisfaction of the virtual reality session.
Secondary Outcome Measures
- State-Trait Anxiety Inventory (STAI) [Completed directly before VR session.]
Measure of participant's baseline state and trait anxiety. Consists of 40 questions based on a 4-point Likert scale. High scores are positively correlated with high levels of anxiety.
- Edinburgh Postnatal depression scale (EPDS) [Completed directly before VR session.]
Measure of participant's baseline depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression.
- State-Trait Anxiety Inventory (STAI) [Completed directly after VR session.]
Measure of participant's state and trait anxiety. Consists of 40 questions based on a 4-point Likert scale. High scores are positively correlated with high levels of anxiety.
- Edinburgh Postnatal depression scale (EPDS) [Completed directly after VR session.]
Measure of participant's depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Currently pregnant or postpartum (delivery within 3 months)
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18 years or older
Exclusion Criteria:
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Unable to participate in study procedures
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English illiterate (surveys validated in English)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Grace Lim, MD, MS
Investigators
- Principal Investigator: Grace Lim, MD,MS, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY21040063