Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Intervention Feasibility
Study Overview
Brief Summary
The purpose of this study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
Intervention Feasibility
Time Frame: Completed immediately after the VR session.
Patient response to the feasibility of VR use. The question asked was, "I was able to do the session without difficulty," which was measured on a Likert Scale of 1-5. A score of 1 is indicative of great difficulty present and a score of 5 is indicative of no difficulty present. Outcome measurement is presented as an averaged score with standard deviation among participating patients.
Intervention Acceptability
Time Frame: Completed directly after the VR intervention session and anxiety/depression measurements.
Acceptability was assessed by questions, "Would you participate in another session?" Acceptability was measured by yes/no responses and reported as an overall percentage of participating patients who responded as yes.
Secondary Outcomes
- Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention(Completed directly before and after VR session.)
- Decrease in Depression From Baseline to Post-intervention(EPDS Completed directly before and after VR session.)
Investigators
Grace Lim, MD, MS
Associate Professor
University of Pittsburgh