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OpenTrials
Completed

NCT Number: NCT03565874

Heart Rate Variability and Prematurity

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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Key information

Conditions

Premature Birth Anxiety Anxiety Disorders Female Urogenital Diseases and Pregnancy Complications Maternal Distress - Delivered Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Stress Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitaliter Universitaire Vaudois

Lausanne, Canton of Vaud, 1004, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility: Acceptance (Ratio)

    Time frame: After completing the HRVB program (on average 3 weeks)

    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

  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 Completed During Study

    Time frame: After completing the HRVB program (on average 3 weeks)

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

  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).

    Higher scores reflects more satisfaction. Possible range 2 to 10.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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