VITALISE: Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Sponsor
Grace Lim, MD, MS (Other)
Overall Status
Completed
CT.gov ID
NCT04925765
Collaborator
(none)
8
1
1
1.4
5.5

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
  • Device: Flowly (TMC-CP01)
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

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Oct 15, 2021

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.

Outcome Measures

Primary Outcome Measures

  1. Post-Session Feasibility and Acceptability [Completed immediately after the VR session.]

    Patient questionnaire on their satisfaction of the virtual reality session.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

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.
Responsible Party:
Grace Lim, MD, MS, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04925765
Other Study ID Numbers:
  • STUDY21040063
First Posted:
Jun 14, 2021
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022