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Premature BirthNCT03565874

Heart Rate Variability and Prematurity

A study testing Heart rate variability biofeedback in people with Premature Birth and Maternal Distress - Delivered, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Heart rate variability biofeedback
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSwitzerland
Study dates
12 Jun 2018to 8 Mar 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitaliter Universitaire Vaudois

    Lausanne, Canton of Vaud, 1004

Other trials in Switzerland

About this study

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

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.

Being tested
Heart rate variability biofeedback
Medical subject headings
Premature Birth, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart rate variability biofeedbackDevice

    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.

Study groups in NCT03565874
Study groupRoleWhat they receive
Heart Rate Variability BiofeedbackExperimentalHRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Receives: Device: Heart rate variability biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Feasibility: Drop-out

    The ratio of drop out.

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

  3. Feasibility: Number of Sessions Completed During Study

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

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

  4. 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.

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

Secondary outcomes (6)

  1. 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.

    Measured: Before and after completing the HRVB program (on average 3 weeks).

  2. HRV: HF

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

    Measured: Before and after completing the HRVB program (on average 3 weeks).

  3. 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.

    Measured: Before and after completing the HRVB program (on average 3 weeks).

  4. 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.

    Measured: Before and after completing the HRVB program (on average 3 weeks).

  5. 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.

    Measured: Before and after completing the HRVB program (on average 3 weeks).

  6. 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.

    Measured: Before and after completing the HRVB program (on average 3 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start12 Jun 2018
  3. Primary completion8 Mar 2019
  4. Study completion8 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03565874
Sponsor's protocol ID
2017-02199
Other IDs
2017
Status last verified
Oct 2019
First submitted
20 Mar 2018
Last updated
15 Oct 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Heart rate variability biofeedback in people with Premature Birth and Maternal Distress - Delivered, run by University of Lausanne Hospitals at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Acceptance (Ratio) (time frame: After completing the HRVB program (on average 3 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03565874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

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Heart Rate Variability and Prematurity (NCT03565874) | AzTrials