Clinical trial NCT03565874: Heart Rate Variability and Prematurity
Official title: Heart Rate Variability Biofeedback (HRVB) With Mothers Who Delivered a Preterm Infant: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Maternal Distress - Delivered
Stress
Anxiety
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Feasibility: Acceptance (Ratio)
timeFrame: After completing the HRVB program (on average 3 weeks)
measure: Feasibility: Drop-out
timeFrame: After completing the HRVB program (on average 3 weeks)
measure: Feasibility: Number of Sessions Completed During Study
timeFrame: After completing the HRVB program (on average 3 weeks)
measure: Satisfaction Regarding the Intervention
timeFrame: After completing the HRVB program (on average 3 weeks)
Secondary outcomes:
measure: HRV: RMSDD
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
measure: HRV: HF
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
measure: Stress
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
measure: PTSD
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
measure: Anxiety
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
measure: Depression
timeFrame: Before and after completing the HRVB program (on average 3 weeks).
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitaliter Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Sébastien Urben, PhD
role: PRINCIPAL_INVESTIGATOR
References: