Heart Rate Variability and Prematurity

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03565874

Enrollment

Registered

2018-06-21

Start date

2018-06-12

Completion date

2019-03-08

Last updated

2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Maternal Distress - Delivered, Premature Birth, Stress

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.

Interventions

DEVICEHeart rate variability biofeedback

Before 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
Heart Rate Variability Biofeedback HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day. Heart rate variability biofeedback: Before 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.	6
Total	6

Arm

Count

Heart Rate Variability Biofeedback

HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day. Heart rate variability biofeedback: Before 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.

Total

Baseline characteristics

Characteristic	Heart Rate Variability Biofeedback	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	6 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Switzerland	6 participants	—
Sex: Female, Male Female	6 Participants	—
Sex: Female, Male Male	0 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	0 / 6
serious Total, serious adverse events	0 / 6

Outcome results

Primary

Feasibility: Acceptance (Ratio)

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

Time frame: After completing the HRVB program (on average 3 weeks)

Population: We propose the study to 18 participants and 6 accept to participate. Ratio: (6/18)\*100

Arm	Measure	Value (NUMBER)
Heart Rate Variability Biofeedback	Feasibility: Acceptance (Ratio)	33.3 percentage of <participants>

Primary

Feasibility: Drop-out

The ratio of drop out.

Time frame: After completing the HRVB program (on average 3 weeks)

Arm	Measure	Value (NUMBER)
Heart Rate Variability Biofeedback	Feasibility: Drop-out	33.3 percentage of participants

Primary

Feasibility: Number of Sessions Completed During Study

Compliance with study protocol regarding the number of sessions attended by the participants.

Time frame: After completing the HRVB program (on average 3 weeks)

Arm	Measure	Value (MEAN)	Dispersion
Heart Rate Variability Biofeedback	Feasibility: Number of Sessions Completed During Study	10.25 sessions completed	Standard Deviation 0.96

Primary

Satisfaction Regarding the Intervention

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.

Time frame: After completing the HRVB program (on average 3 weeks)

Arm	Measure	Value (MEAN)	Dispersion
Heart Rate Variability Biofeedback	Satisfaction Regarding the Intervention	7.5 score on a scale	Standard Deviation 0.57

Secondary

Anxiety

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.