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Mothers who deliver prematurely (<37 weeks of gestational age) experience intense stress and anxiety given that their child's survival and development might be compromised. From the existing literature, it is known that a heart rate variability biofeedback (HRVB) program increases heart rate variability (HRV), which in turn, is related to significant reductions in perceived stress and anxiety. This study's aim is to evaluate the feasibility of an HRVB program in a sample of mothers who delivered prematurely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Rate Variability Biofeedback | Experimental | HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability biofeedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Acceptance (Ratio) | 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 | After completing the HRVB program (on average 3 weeks) |
| Feasibility: Drop-out | The ratio of drop out. | After completing the HRVB program (on average 3 weeks) |
| Feasibility: Number of Sessions Completed During Study | Compliance with study protocol regarding the number of sessions attended by the participants. | After completing the HRVB program (on average 3 weeks) |
| Satisfaction Regarding the Intervention | 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. | After completing the HRVB program (on average 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| HRV: RMSDD | 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. | Before and after completing the HRVB program (on average 3 weeks). |
| HRV: HF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Urben, PhD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitaliter Universitaire Vaudois | Lausanne | Canton of Vaud | 1004 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Feasibility: Acceptance (Ratio) | 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 | We propose the study to 18 participants and 6 accept to participate. Ratio: (6/18)*100 | Posted | Number | percentage of <participants> | After completing the HRVB program (on average 3 weeks) |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sébastien Urben | Department of Child and Adolescent Psychiatry, University Hospital of Lausanne | +41 21 314 7492 | sebastien.urben@chuv.ch |
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| 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 | Jul 24, 2019 | Jul 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program. |
| Before and after completing the HRVB program (on average 3 weeks). |
| Stress | 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. | Before and after completing the HRVB program (on average 3 weeks). |
| PTSD | 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. | Before and after completing the HRVB program (on average 3 weeks). |
| Anxiety | 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. | Before and after completing the HRVB program (on average 3 weeks). |
| Depression | 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. | Before and after completing the HRVB program (on average 3 weeks). |
| Participants |
|
| 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 | participants |
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| Primary | Feasibility: Drop-out | The ratio of drop out. | Posted | Number | percentage of participants | After completing the HRVB program (on average 3 weeks) |
|
|
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| Primary | Feasibility: Number of Sessions Completed During Study | Compliance with study protocol regarding the number of sessions attended by the participants. | Posted | Mean | Standard Deviation | sessions completed | After completing the HRVB program (on average 3 weeks) |
|
|
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| Primary | Satisfaction Regarding the Intervention | 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. | Posted | Mean | Standard Deviation | score on a scale | After completing the HRVB program (on average 3 weeks) |
|
|
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| Secondary | HRV: RMSDD | 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. | Posted | Mean | Standard Deviation | milliseconds | Before and after completing the HRVB program (on average 3 weeks). |
|
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| Secondary | HRV: HF | High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program. | Posted | Mean | Standard Deviation | high frequency power normalized unit | Before and after completing the HRVB program (on average 3 weeks). |
|
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| Secondary | Stress | 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. | Posted | Mean | Standard Deviation | score on a scale | Before and after completing the HRVB program (on average 3 weeks). |
|
|
|
| Secondary | PTSD | 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. | Posted | Mean | Standard Deviation | score on a scale | Before and after completing the HRVB program (on average 3 weeks). |
|
|
|
| Secondary | Anxiety | 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. | Posted | Mean | Standard Deviation | score on a scale | Before and after completing the HRVB program (on average 3 weeks). |
|
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| Secondary | Depression | 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. | Posted | Mean | Standard Deviation | score on a scale | Before and after completing the HRVB program (on average 3 weeks). |
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| 6 |
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| 6 |
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| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
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| STAI state - After intervention |
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