Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality (VR) Session | Experimental | All participants in this study will complete a 1 hour virtual reality session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Grace Lim, MD,MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29914574 | Background | 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. | |
| 33964789 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All women who were willing to participate received the same treatment arm, VR biofeedback session.
Postpartum women with a history of anxiety (ANX) or depression (DEP) participated in a single virtual reality (VR) biofeedback session.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Session | All participants in this study will complete a 1 hour virtual reality session. Flowly (TMC-CP01): The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Session | All participants in this study will complete a 1 hour virtual reality session. Flowly (TMC-CP01): The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | postpartum women | Posted | Mean | Standard Deviation | score on a scale | Completed immediately after the VR session. |
|
Within the study intervention of 2 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Session | All participants in this study will complete a 1 hour virtual reality session. Flowly (TMC-CP01): The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression. |
Not provided
Not provided
The study is limited by the exploratory nature and small sample size, but feasibility is appropriate to assess in a clinical setting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Grace Lim | University of Pittsburgh Medical Center | 4126411777 | limkg2@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2023 | Apr 9, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention. |
| Completed directly before and after VR session. |
| 34036696 | 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. |
| 33952318 | 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. |
| 33820786 | 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. |
| 33792548 | 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. |
| 33689452 | 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. |
| 33683433 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | number of participants |
|
| Anxiety | Measure of participant's baseline state and trait anxiety. Consists of 40 questions based on a 4-point Likert scale. High scores are positively correlated with high levels of anxiety. Scores range from 0-120. | Mean | Standard Deviation | units on a scale |
|
| Depression at baseline | Baseline depression measured via Edinburgh Postnatal Depression Scale, a 10-item questionnaire with a minimum score of 0 and a maximum score of 30. A score of 10 or greater is indicative of possible depression, a score of 14 or greater is indicative of severe depression. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | postpartum women | Posted | Count of Participants | Participants | 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. | number of participants whose depression scores decreased. | Posted | Count of Participants | Participants | 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. | Number of participants with decreases in anxiety scores pre-post. | Posted | Count of Participants | Participants | Completed directly before and after VR session. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
Not provided
Not provided
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |