Trial Outcomes & Findings for Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women (NCT NCT02119936)
NCT ID: NCT02119936
Last Updated: 2018-03-19
Results Overview
The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.
TERMINATED
NA
10 participants
Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)
2018-03-19
Participant Flow
Women were recruited from the antepartum unit of the North Carolina Women's Hospital to participate in the study.
Participant milestones
| Measure |
Heart Rate Variability Biofeedback
Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback (HRVB) tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
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|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Heart Rate Variability Biofeedback
Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback (HRVB) tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
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|---|---|
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Overall Study
Lost to Follow-up
|
10
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Baseline Characteristics
Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women
Baseline characteristics by cohort
| Measure |
Heart Rate Variability Biofeedback
n=10 Participants
Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
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|---|---|
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Age, Continuous
|
30.8 years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
|
Education status
Less than high school
|
1 Participants
n=5 Participants
|
|
Education status
High school diploma or GED equivalent
|
2 Participants
n=5 Participants
|
|
Education status
Some college credit, no degree
|
4 Participants
n=5 Participants
|
|
Education status
Associate's degree
|
1 Participants
n=5 Participants
|
|
Education status
Bachelor's degree
|
1 Participants
n=5 Participants
|
|
Education status
Graduate level degree
|
1 Participants
n=5 Participants
|
|
Relationship status
Single/never married
|
1 participants
n=5 Participants
|
|
Relationship status
Committed Relationship
|
4 participants
n=5 Participants
|
|
Relationship status
Married
|
4 participants
n=5 Participants
|
|
Relationship status
Divorced/separated
|
2 participants
n=5 Participants
|
|
Relationship status
Widowed
|
0 participants
n=5 Participants
|
|
Insurance provider
Medicaid
|
5 Participants
n=5 Participants
|
|
Insurance provider
Private Insurance
|
5 Participants
n=5 Participants
|
|
Insurance provider
Tricare
|
0 Participants
n=5 Participants
|
|
Insurance provider
Uninsured
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=10 Participants
Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
|
|---|---|
|
Feasibility of Using HRVB Among Hospitalized Pregnant Women
Participants enrolled
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10 Participants
|
|
Feasibility of Using HRVB Among Hospitalized Pregnant Women
Participants with a 5-7 day inpatient follow-up
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0 Participants
|
|
Feasibility of Using HRVB Among Hospitalized Pregnant Women
Participants with a follow up phone call
|
0 Participants
|
|
Feasibility of Using HRVB Among Hospitalized Pregnant Women
Participants completed
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0 Participants
|
SECONDARY outcome
Timeframe: Baseline to in-patient follow-up (5 to 7 days in between)Population: No in-patient follow up was completed due to patients moving off antepartum unit prior to meeting the 5-7 day in-patient criteria
State-trait anxiety scores range from 40-80 with higher scores indicative of greater anxiety
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to in-patient follow-up (5 to 7 days in between)Population: HF-HRV data was not collected
The investigators will measure HF-HRV in 1-minute segments during HRVB, and will test whether coherence score, as recorded by the HRVB device, correlates with HF-HRV.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to in-patient follow-up (5 to 7 days in between)Population: All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these data were not collected.
The investigators will stratify our population based on the depression screen used at the baseline visit. These groups will include those with severe, moderate, or lack of depression. The investigators will then compare these groups to the finds from the surveys on maternal mood and the difference noticed among the groups due to the HRVB tools.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to in-patient follow-up (5 to 7 days in between)Population: All participants were discharged from antepartum unit prior to 5-7 days in-patient so these study data were not collected.
The Linear Analog Self-Assessment (LASA) form measures patient quality-of-life. Scores range from 6-30 with higher scores indicative of greater well-being.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to in-patient follow-up (5 to 7 days in between)Population: All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these study data were not collected.
The Warwick Edinburgh Mental Well Being Scale is a 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.
Outcome measures
Outcome data not reported
Adverse Events
Heart Rate Variability Biofeedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place