ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart Rate Variability and Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03565874
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Urben Sébastien, University of Lausanne Hospitals

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.

Condition or disease Intervention/treatment Phase
Premature Birth Maternal Distress - Delivered Stress Anxiety Device: Heart rate variability biofeedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Heart Rate Variability Biofeedback (HRVB) With Mothers Who Delivered a Preterm Infant: A Feasibility Study
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Heart Rate Variability Biofeedback
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Device: 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.




Primary Outcome Measures :
  1. Feasibility: Acceptance [ Time Frame: After completing the HRVB program (on average 3 weeks) ]
    The ratio of acceptance of study participation

  2. Feasibility: Drop-out [ Time Frame: After completing the HRVB program (on average 3 weeks) ]
    The ratio of drop out.

  3. Feasibility: Number of sessions [ Time Frame: After completing the HRVB program (on average 3 weeks) ]
    Compliance with study protocol

  4. Satisfaction regarding the intervention [ Time Frame: 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).


Secondary Outcome Measures :
  1. HRV: RMSDD [ Time Frame: 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.

  2. HRV: HF [ Time Frame: 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.

  3. Stress [ Time Frame: 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.

  4. PTSD [ Time Frame: 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.

  5. Anxiety [ Time Frame: 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.


  6. Depression [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565874


Contacts
Contact: Sébastien Urben, PhD +41213147492 sebastien.urben@chuv.ch

Locations
Switzerland
Centre Hospitaliter Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1004
Contact: Sebastien Urben, PhD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Sébastien Urben, PhD Centre Hospitalier Universitaire Vaudois

Responsible Party: Urben Sébastien, Head of Research Unit, University Service of Child and Adolescent Psychiatry, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03565874     History of Changes
Other Study ID Numbers: 2017-02199
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications