Virtual Reality Biofeedback for Postpartum Anxiety and Depression

NCT04925765 | Completed Results

• 1 other identifier: STUDY21040063
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Depression; Postpartum Depression; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (2)

• Decrease in Depression From Baseline to Post-intervention

  EPDS Completed directly before and after VR session.

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

  Completed directly before and after VR session.

Study Arms (1)

Virtual Reality (VR) Session

EXPERIMENTAL

All participants in this study will complete a 1 hour virtual reality session.

Other: Virtual Reality Biofeedback Session

Interventions

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.

Virtual Reality (VR) Session

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently pregnant or postpartum (delivery within 3 months)
• years or older

You may not qualify if:

• Unable to participate in study procedures
• English illiterate (surveys validated in English)

Sponsors & Collaborators

• Grace Lim, MD, MS: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.

  PMID: 29914574 BACKGROUND

• Kolbe L, Jaywant A, Gupta A, Vanderlind WM, Jabbour G. Use of virtual reality in the inpatient rehabilitation of COVID-19 patients. Gen Hosp Psychiatry. 2021 Jul-Aug;71:76-81. doi: 10.1016/j.genhosppsych.2021.04.008. Epub 2021 Apr 29.

  PMID: 33964789 BACKGROUND

• Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.

  PMID: 34036696 BACKGROUND

• Vlake JH, Van Bommel J, Wils EJ, Korevaar TIM, Hellemons ME, Schut AFC, Labout JAM, Schreuder LLH, Gommers D, Van Genderen ME. Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial. Trials. 2021 May 5;22(1):328. doi: 10.1186/s13063-021-05271-z.

  PMID: 33952318 BACKGROUND

• Sasseville M, LeBlanc A, Boucher M, Dugas M, Mbemba G, Tchuente J, Chouinard MC, Beaulieu M, Beaudet N, Skidmore B, Cholette P, Aspiros C, Larouche A, Chabot G, Gagnon MP. Digital health interventions for the management of mental health in people with chronic diseases: a rapid review. BMJ Open. 2021 Apr 5;11(4):e044437. doi: 10.1136/bmjopen-2020-044437.

  PMID: 33820786 BACKGROUND

• Alneyadi M, Drissi N, Almeqbaali M, Ouhbi S. Biofeedback-Based Connected Mental Health Interventions for Anxiety: Systematic Literature Review. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e26038. doi: 10.2196/26038.

  PMID: 33792548 BACKGROUND

• Polat M, Kahveci A, Muci B, Gunendi Z, Kaymak Karatas G. The Effect of Virtual Reality Exercises on Pain, Functionality, Cardiopulmonary Capacity, and Quality of Life in Fibromyalgia Syndrome: A Randomized Controlled Study. Games Health J. 2021 Jun;10(3):165-173. doi: 10.1089/g4h.2020.0162. Epub 2021 Mar 9.

  PMID: 33689452 BACKGROUND

• Turrado V, Guzman Y, Jimenez-Lillo J, Villegas E, de Lacy FB, Blanch J, Balibrea JM, Lacy A. Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial. Surg Endosc. 2021 Jul;35(7):4042-4047. doi: 10.1007/s00464-021-08407-z. Epub 2021 Mar 8.

  PMID: 33683433 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Depression, Postpartum

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Limitations and Caveats

The study is limited by the exploratory nature and small sample size, but feasibility is appropriate to assess in a clinical setting.

Results Point of Contact

• Title: Dr. Katherine Grace Lim
• Organization: University of Pittsburgh Medical Center

limkg2@upmc.edu

4126411777

Study Officials

• Grace Lim, MD,MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 15, 2021
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)