Back to resultsVirtual Reality Biofeedback for Postpartum Anxiety and Depression (VITALISE)
Primary Purpose
Anxiety and Depression, Postpartum Depression, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flowly (TMC-CP01)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety and Depression
Eligibility Criteria
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)
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality Session
Arm Description
All participants in this study will complete a 1 hour virtual reality session.
Outcomes
Primary Outcome Measures
Post-Session Feasibility and Acceptability
Patient questionnaire on their satisfaction of the virtual reality session.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04925765
Brief Title
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Acronym
VITALISE
Official Title
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grace Lim, MD, MS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Depression, Postpartum Depression, Pregnancy Related
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Session
Arm Type
Experimental
Arm Description
All participants in this study will complete a 1 hour virtual reality session.
Intervention Type
Device
Intervention Name(s)
Flowly (TMC-CP01)
Intervention Description
The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.
Primary Outcome Measure Information:
Title
Post-Session Feasibility and Acceptability
Description
Patient questionnaire on their satisfaction of the virtual reality session.
Time Frame
Completed immediately after the VR session.
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Completed directly before VR session.
Title
Edinburgh Postnatal depression scale (EPDS)
Description
Measure of participant's baseline depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression.
Time Frame
Completed directly before VR session.
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Completed directly after VR session.
Title
Edinburgh Postnatal depression scale (EPDS)
Description
Measure of participant's depression. Consists of 10 questions based on a 0-3 scale. Scores 10 and greater indicate signs of depression.
Time Frame
Completed directly after VR session.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Lim, MD,MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
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