Heart Rate Variability and Prematurity

Not Applicable

Completed

Conditions: Premature Birth
Stress
Maternal Distress - Delivered
Anxiety

Interventions: Device: Heart rate variability biofeedback

Registration Number: NCT03565874

Lead Sponsor: University of Lausanne Hospitals

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Rate Variability Biofeedback	Heart rate variability biofeedback	HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.

Primary Outcome Measures

Name	Time	Method
Satisfaction Regarding the Intervention	After completing the HRVB program (on average 3 weeks)	Satisfaction will be measured through a questionnaire. Questions will be asked about global satisfaction, utility, timing and difficulty about their experience (assessed on single item Likert scale). Higher scores reflects more satisfaction. Possible range 2 to 10.
Feasibility: Acceptance (Ratio)	After completing the HRVB program (on average 3 weeks)	The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) \* 100
Feasibility: Drop-out	After completing the HRVB program (on average 3 weeks)	The ratio of drop out.
Feasibility: Number of Sessions Completed During Study	After completing the HRVB program (on average 3 weeks)	Compliance with study protocol regarding the number of sessions attended by the participants.

Secondary Outcome Measures

Name	Time	Method
HRV: HF	Before and after completing the HRVB program (on average 3 weeks).	High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.
Stress	Before and after completing the HRVB program (on average 3 weeks).	Perceived stress will be measured on the Perceived Stress Scale-14 (PSS-14). PSS-14 score is calculated on 14 items ranging from 0 to 4. The 7 positive state items (4,5,6,7,9,10 and 13) must have their score reversed (0=4, 1=3, 2=2, 3=1, 4=0) in order to calculate the total score by summing up all 14 items.(Min=0, Max=56). Higher scores indicate a higher level of stress. A validated French version of the PSS will be used.
PTSD	Before and after completing the HRVB program (on average 3 weeks).	Post-traumatic stress disorder symptoms will be measured with the Post-traumatic stress disorder checklist (PCL-5) for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5). PCL-5 is a 20 items self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond to DSM-5 criteria for PTSD. Each item is rated on a 5 point Likert scale (from "Not at all" to "Extremely"). Total score is calculated by adding up scores for all items (Min = 0, Max = 80). Higher scores indicate a higher level of PTSD. A validated French version of the PCL will be used.
Anxiety	Before and after completing the HRVB program (on average 3 weeks).	Anxiety symptoms will be measured with the State and Trait Anxiety Inventory (STAI). STAI score is calculated on 40 items (20 items assessing trait anxiety and 20 items assessing state anxiety) rated on a 4 point Likert scale (from "Almost never" to "Almost always"). Total score for state and trait anxiety is calculated by adding up all items (Min = 20, Max = 80). Higher scores indicate a higher level of anxiety. A validated French version of the STAI will be used.
HRV: RMSDD	Before and after completing the HRVB program (on average 3 weeks).	The root-mean square differences of successive R-R intervals (RMSDD) will be used as measures to assess HRV level before and after participation in the HRVB program.
Depression	Before and after completing the HRVB program (on average 3 weeks).	Depression symptoms will be assessed with a 13-item short form of the Beck Depression Inventory (BDI), which is a 13-item, self-report rating inventory that measures symptoms of depression. The scale for each item goes from 0 to 3. Total score is calculated by adding up scores from each item (Min = 0, Max = 39). Higher scores indicate a higher level of depression. A validated French version of the BDI will be used.