N/A
N=6
Heart Rate Variability and Prematurity
Premature Birth · Maternal Distress - Delivered · Stress · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03565874 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Feasibility: Acceptance (Ratio) — 33.3 percentage of <participants>
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart rate variability biofeedback (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Lausanne Hospitals
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Acceptance (Ratio) |
33.3 | — |
| PRIMARY Feasibility: Drop-out |
33.3 | — |
| PRIMARY Feasibility: Number of Sessions Completed During Study |
10.25 | — |
| PRIMARY Satisfaction Regarding the Intervention |
7.5 | — |
| SECONDARY HRV: RMSDD |
42.7; 49.13 | — |
| SECONDARY HRV: HF |
45.63; 27.81 | — |
| SECONDARY Stress |
29; 19.75 | — |
| SECONDARY PTSD |
27.75; 16.25 | — |
| SECONDARY Anxiety |
32.75; 32.25; 49.25; 34.5 | — |
| SECONDARY Depression |
4.75; 3.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03565874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.