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Heart Rate Variability and Prematurity

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Maternal Distress - Delivered
Anxiety
Stress
Premature Birth

Treatments

Device: Heart rate variability biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT03565874
2017-02199

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Heart Rate Variability Biofeedback
Experimental group
Description:
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
Treatment:
Device: Heart rate variability biofeedback

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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