Clinical trial NCT04925765: Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Official title: Virtual Reality Biofeedback for Postpartum Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Depression
Postpartum Depression
Pregnancy Related
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Intervention Feasibility
timeFrame: Completed immediately after the VR session.
measure: Intervention Acceptability
timeFrame: Completed directly after the VR intervention session and anxiety/depression measurements.
Secondary outcomes:
measure: Decrease in Depression From Baseline to Post-intervention
timeFrame: EPDS Completed directly before and after VR session.
measure: Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention
timeFrame: Completed directly before and after VR session.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD,MS
role: PRINCIPAL_INVESTIGATOR
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