Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Not Applicable

Completed

• Conditions: Postpartum Depression; Anxiety and Depression; Pregnancy Related
• Interventions: Other: Virtual Reality Biofeedback Session

• Registration Number: NCT04925765
• Lead Sponsor: Grace Lim, MD, MS

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 Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-14
• Study Start: 2021-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-15
• Results First Submitted: 2022-09-28
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality (VR) Session	Virtual Reality Biofeedback Session	All participants in this study will complete a 1 hour virtual reality session.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility	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	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 Outcome Measures

Name	Time	Method
Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention	Completed directly before and after VR session.	Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention.
Decrease in Depression From Baseline to Post-intervention	EPDS Completed directly before and after VR session.	Number of participants whose depression scores (as measured by Edinburgh Postnatal depression scale (EPDS)) decreased from baseline to post-VR intervention.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States