Heart Rate Variability and Prematurity

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Heart rate variability biofeedback

About this trial

This is an interventional device feasibility trial for Premature Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Delivery between 33 and 37 weeks of gestational age
Living in Lausanne or surroundings
Infant is expected to survive
Singleton birth
Consent of mother to participate in the study
Sufficient French-speaking skills to fill out the questionnaires
Mothers older than 18 years of age

Exclusion Criteria:

Infant with cranial abnormality/neurological squeal such as cystic periventricular leukomalacia (PVL) and intraventricular haemorrhage (IVH)
Maternal history of drug or alcohol abuse or severe psychiatric disorders before or during pregnancy
Infant with congenital anomalies
Infant with hearing or vision loss
Mother and infant participating in another clinical trial

Sites / Locations

Centre Hospitaliter Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Rate Variability Biofeedback

Arm Description

HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.

Outcomes

Primary Outcome Measures

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

Feasibility: Drop-out

The ratio of drop out.

Feasibility: Number of Sessions Completed During Study

Compliance with study protocol regarding the number of sessions attended by the participants.

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.

Secondary Outcome Measures

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.

HRV: HF

High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.

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.

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.

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.

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.

Full Information

NCT ID

NCT03565874

First Posted

March 20, 2018

Last Updated

October 14, 2019

Sponsor

University of Lausanne Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT03565874

Brief Title

Heart Rate Variability and Prematurity

Official Title

Heart Rate Variability Biofeedback (HRVB) With Mothers Who Delivered a Preterm Infant: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 12, 2018 (Actual)

Primary Completion Date

March 8, 2019 (Actual)

Study Completion Date

March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth, Maternal Distress - Delivered, Stress, Anxiety

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heart Rate Variability Biofeedback

Arm Type

Experimental

Arm Description

HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.

Intervention Type

Device

Intervention Name(s)

Heart rate variability biofeedback

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility: Acceptance (Ratio)

Description

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

Time Frame

After completing the HRVB program (on average 3 weeks)

Title

Feasibility: Drop-out

Description

The ratio of drop out.

Time Frame

After completing the HRVB program (on average 3 weeks)

Title

Feasibility: Number of Sessions Completed During Study

Description

Compliance with study protocol regarding the number of sessions attended by the participants.

Time Frame

After completing the HRVB program (on average 3 weeks)

Title

Satisfaction Regarding the Intervention

Description

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.

Time Frame

After completing the HRVB program (on average 3 weeks)

Secondary Outcome Measure Information:

Title

HRV: RMSDD

Description

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.

Time Frame