Trial Outcomes & Findings for Heart Rate Variability and Prematurity (NCT NCT03565874)
NCT ID: NCT03565874
Last Updated: 2019-10-15
Results Overview
The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) \* 100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
After completing the HRVB program (on average 3 weeks)
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Heart Rate Variability Biofeedback
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Heart Rate Variability Biofeedback
n=6 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Age, Categorical
<=18 years
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0 Participants
n=6 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=6 Participants
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Age, Categorical
>=65 years
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0 Participants
n=6 Participants
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Sex: Female, Male
Female
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6 Participants
n=6 Participants
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Sex: Female, Male
Male
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0 Participants
n=6 Participants
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Region of Enrollment
Switzerland
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6 participants
n=6 Participants
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PRIMARY outcome
Timeframe: After completing the HRVB program (on average 3 weeks)Population: We propose the study to 18 participants and 6 accept to participate. Ratio: (6/18)\*100
The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) \* 100
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=18 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Feasibility: Acceptance (Ratio)
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33.3 percentage of <participants>
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PRIMARY outcome
Timeframe: After completing the HRVB program (on average 3 weeks)The ratio of drop out.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=6 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Feasibility: Drop-out
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33.3 percentage of participants
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PRIMARY outcome
Timeframe: After completing the HRVB program (on average 3 weeks)Compliance with study protocol regarding the number of sessions attended by the participants.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Feasibility: Number of Sessions Completed During Study
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10.25 sessions completed
Standard Deviation 0.96
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PRIMARY outcome
Timeframe: After completing the HRVB program (on average 3 weeks)Satisfaction will be measured through a questionnaire. Questions will be asked about global satisfaction, utility, timing and difficulty about their experience (assessed on single item Likert scale). Higher scores reflects more satisfaction. Possible range 2 to 10.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Satisfaction Regarding the Intervention
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7.5 score on a scale
Standard Deviation 0.57
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).The root-mean square differences of successive R-R intervals (RMSDD) will be used as measures to assess HRV level before and after participation in the HRVB program.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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HRV: RMSDD
Before intervention
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42.7 milliseconds
Standard Deviation 24.76
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HRV: RMSDD
After intervention
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49.13 milliseconds
Standard Deviation 37.04
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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HRV: HF
Before intervention
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45.63 high frequency power normalized unit
Standard Deviation 11.16
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HRV: HF
After intervention
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27.81 high frequency power normalized unit
Standard Deviation 14.12
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).Perceived stress will be measured on the Perceived Stress Scale-14 (PSS-14). PSS-14 score is calculated on 14 items ranging from 0 to 4. The 7 positive state items (4,5,6,7,9,10 and 13) must have their score reversed (0=4, 1=3, 2=2, 3=1, 4=0) in order to calculate the total score by summing up all 14 items.(Min=0, Max=56). Higher scores indicate a higher level of stress. A validated French version of the PSS will be used.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Stress
Before intervention
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29 score on a scale
Standard Deviation 9.97
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Stress
After intervention
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19.75 score on a scale
Standard Deviation 14.24
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).Post-traumatic stress disorder symptoms will be measured with the Post-traumatic stress disorder checklist (PCL-5) for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5). PCL-5 is a 20 items self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond to DSM-5 criteria for PTSD. Each item is rated on a 5 point Likert scale (from "Not at all" to "Extremely"). Total score is calculated by adding up scores for all items (Min = 0, Max = 80). Higher scores indicate a higher level of PTSD. A validated French version of the PCL will be used.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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PTSD
Before intervention
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27.75 score on a scale
Standard Deviation 15.73
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PTSD
After intervention
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16.25 score on a scale
Standard Deviation 12.69
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).Anxiety symptoms will be measured with the State and Trait Anxiety Inventory (STAI). STAI score is calculated on 40 items (20 items assessing trait anxiety and 20 items assessing state anxiety) rated on a 4 point Likert scale (from "Almost never" to "Almost always"). Total score for state and trait anxiety is calculated by adding up all items (Min = 20, Max = 80). Higher scores indicate a higher level of anxiety. A validated French version of the STAI will be used.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Anxiety
STAI trait - Before intervention
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32.75 score on a scale
Standard Deviation 8.46
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Anxiety
STAI trait - After intervention
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32.25 score on a scale
Standard Deviation 6.65
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Anxiety
STAI state - Before intervention
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49.25 score on a scale
Standard Deviation 18.46
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Anxiety
STAI state - After intervention
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34.5 score on a scale
Standard Deviation 7.59
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SECONDARY outcome
Timeframe: Before and after completing the HRVB program (on average 3 weeks).Depression symptoms will be assessed with a 13-item short form of the Beck Depression Inventory (BDI), which is a 13-item, self-report rating inventory that measures symptoms of depression. The scale for each item goes from 0 to 3. Total score is calculated by adding up scores from each item (Min = 0, Max = 39). Higher scores indicate a higher level of depression. A validated French version of the BDI will be used.
Outcome measures
| Measure |
Heart Rate Variability Biofeedback
n=4 Participants
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
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Depression
Before intervention
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4.75 score on a scale
Standard Deviation 4.57
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Depression
After intervention
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3.5 score on a scale
Standard Deviation 1
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Adverse Events
Heart Rate Variability Biofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sébastien Urben
Department of Child and Adolescent Psychiatry, University Hospital of Lausanne
Phone: +41 21 314 7492
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place