Trial Outcomes & Findings for Virtual Reality Biofeedback for Postpartum Anxiety and Depression (NCT NCT04925765)
NCT ID: NCT04925765
Last Updated: 2024-04-17
Results Overview
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
NA
6 participants
Completed immediately after the VR session.
2024-04-17
Participant Flow
Postpartum women with a history of anxiety (ANX) or depression (DEP) participated in a single virtual reality (VR) biofeedback session.
All women who were willing to participate received the same treatment arm, VR biofeedback session.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Virtual Reality Session
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 4.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
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6 number of participants
n=6 Participants
|
|
Anxiety
|
42.3 units on a scale
STANDARD_DEVIATION 10.3 • n=6 Participants
|
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Depression at baseline
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6.3 units on a scale
STANDARD_DEVIATION 3.5 • n=6 Participants
|
PRIMARY outcome
Timeframe: Completed immediately after the VR session.Population: postpartum women
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.
Outcome measures
| Measure |
Virtual Reality Session
n=6 Participants
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.
|
|---|---|
|
Intervention Feasibility
|
4.83 score on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: Completed directly after the VR intervention session and anxiety/depression measurements.Population: postpartum women
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.
Outcome measures
| Measure |
Virtual Reality Session
n=6 Participants
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.
|
|---|---|
|
Intervention Acceptability
|
5 Participants
|
SECONDARY outcome
Timeframe: EPDS Completed directly before and after VR session.Population: number of participants whose depression scores decreased.
Number of participants whose depression scores (as measured by Edinburgh Postnatal depression scale (EPDS)) decreased from baseline to post-VR intervention.
Outcome measures
| Measure |
Virtual Reality Session
n=6 Participants
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.
|
|---|---|
|
Decrease in Depression From Baseline to Post-intervention
|
5 Participants
|
SECONDARY outcome
Timeframe: Completed directly before and after VR session.Population: Number of participants with decreases in anxiety scores pre-post.
Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention.
Outcome measures
| Measure |
Virtual Reality Session
n=6 Participants
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.
|
|---|---|
|
Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention
|
5 Participants
|
Adverse Events
Virtual Reality Session
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Katherine Grace Lim
University of Pittsburgh Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place