Heart Rate Variability and Prematurity

NCT ID: NCT03565874

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2019-03-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Heart Rate Variability Biofeedback

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

Group Type: EXPERIMENTAL

Heart rate variability biofeedback

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Urben Sébastien

Head of Research Unit, University Service of Child and Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sébastien Urben, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitaliter Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-02199

Identifier Type: -

Identifier Source: org_study_id