Clinical Trials Directory

Trials / Completed

CompletedNCT03565874

Heart Rate Variability and Prematurity

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Lausanne Hospitals · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICEHeart rate variability biofeedbackBefore 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.

Timeline

Start date
2018-06-12
Primary completion
2019-03-08
Completion
2019-03-08
First posted
2018-06-21
Last updated
2019-10-15
Results posted
2019-08-29

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03565874. Inclusion in this directory is not an endorsement.

Heart Rate Variability and Prematurity (NCT03565874) · Clinical Trials Directory