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OpenTrials
Completed

NCT Number: NCT04925765

Virtual Reality Biofeedback for Postpartum Anxiety and Depression

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.

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Key information

Conditions

Anxiety and Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Complications Pregnancy Related Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual Reality Biofeedback Session

Other

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

Primary outcomes

  1. 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.

  2. 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

  1. Decrease in Depression From Baseline to Post-intervention

    Time frame: 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.

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

    Time frame: Completed directly before and after VR session.

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

Sponsors and collaborators

Lead sponsor

Grace Lim, MD, MS

Other

Registry information

Acronym: VITALISE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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