Anxiety and Depression, Postpartum Depression, Pregnancy Related
Conditions
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.
Detailed 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.
Interventions
OTHERVirtual 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.
Sponsors
Grace Lim, MD, MS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | 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. |
| Intervention Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Depression From Baseline to Post-intervention | 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. |
| Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention | Completed directly before and after VR session. | Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention. |
Countries
United States
Participant flow
Recruitment details
Postpartum women with a history of anxiety (ANX) or depression (DEP) participated in a single virtual reality (VR) biofeedback session.
Pre-assignment details
All women who were willing to participate received the same treatment arm, VR biofeedback session.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Virtual Reality Session | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 33.9 years STANDARD_DEVIATION 4.9 | — |
| Anxiety | 42.3 units on a scale STANDARD_DEVIATION 10.3 | — |
| Depression at baseline | 6.3 units on a scale STANDARD_DEVIATION 3.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 6 number of participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Completed directly after the VR intervention session and anxiety/depression measurements.
Population: postpartum women
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Session | Intervention Acceptability | 5 Participants |
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.
Time frame: Completed immediately after the VR session.
Population: postpartum women
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Session | Intervention Feasibility | 4.83 score on a scale | Standard Deviation 0.41 |
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.
Time frame: EPDS Completed directly before and after VR session.
Population: number of participants whose depression scores decreased.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Session | Decrease in Depression From Baseline to Post-intervention | 5 Participants |
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.
Time frame: Completed directly before and after VR session.
Population: Number of participants with decreases in anxiety scores pre-post.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Session | Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention | 5 Participants |