Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Pregnancy Related Clinical Trial

— VITALISE  

Official title:

Virtual Reality Biofeedback for Postpartum Anxiety and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925765
• Other study ID #: STUDY21040063
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 15, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety and Depression
• Anxiety Disorders
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression
• Pregnancy Related

Intervention

Other:
• Virtual Reality Biofeedback Session
The "Flowly" intervention treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Grace Lim, MD, MS

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	EPDS Completed directly before and after VR session.
Secondary	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.	Completed directly before and after VR session.