Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Conditions
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Anxiety and Depression, Postpartum Depression, Pregnancy Related

Intervention / Treatment
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* Device: Flowly (TMC-CP01)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently pregnant or postpartum (delivery within 3 months) 18 years or older Exclusion Criteria: Unable to participate in study procedures English illiterate (surveys validated in English)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Session<br>All participants in this study will complete a 1 hour virtual reality session. | Device: Flowly (TMC-CP01)<br>* The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Session Feasibility and Acceptability | Patient questionnaire on their satisfaction of the virtual reality session. | Completed immediately after the VR session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | 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. | Completed directly before VR session. | 
| Edinburgh Postnatal depression scale (EPDS) | Measure of participant's baseline depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression. | Completed directly before VR session. | 
| State-Trait Anxiety Inventory (STAI) | 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. | Completed directly after VR session. | 
| Edinburgh Postnatal depression scale (EPDS) | Measure of participant's depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression. | Completed directly after VR session. |