Heart Rate Variability and Prematurity

NCT03565874 | Completed Results

• 1 other identifier: 2017-02199
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Maternal Distress - Delivered; Stress; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (6)

• HRV: RMSDD

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

• HRV: HF

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

• Stress

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

• PTSD

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

• Anxiety

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

Study Arms (1)

Heart Rate Variability Biofeedback

EXPERIMENTAL

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

Device: Heart rate variability biofeedback

Interventions

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.

Heart Rate Variability Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre Hospitaliter Universitaire Vaudois

Lausanne, Canton of Vaud, 1004, Switzerland

Location

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Sébastien Urben
• Organization: Department of Child and Adolescent Psychiatry, University Hospital of Lausanne

[email protected]

+41 21 314 7492

Study Officials

• Sébastien Urben, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Unit, University Service of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: June 21, 2018
• Study Start: June 12, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: October 15, 2019
• Results First Posted: August 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)