Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Grace Lim, MD, MS6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anxiety and Depression Postpartum Depression Pregnancy Related

Interventions

Virtual Reality Biofeedback SessionOTHER

The "Flowly" intervention treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Intervention Feasibility

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.

Time frame: Completed immediately after the VR session.

Intervention Acceptability

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.

Time frame: Completed directly after the VR intervention session and anxiety/depression measurements.

Secondary Outcomes

Decrease in Depression From Baseline to Post-intervention

Number of participants whose depression scores (as measured by Edinburgh Postnatal depression scale (EPDS)) decreased from baseline to post-VR intervention.

Time frame: EPDS Completed directly before and after VR session.

Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention

Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention.

Time frame: Completed directly before and after VR session.

Data from ClinicalTrials.gov

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