Heart Rate Variability and Prematurity

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565874
• Other study ID #: 2017-02199
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: October 2019
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Maternal Distress - Delivered
• Premature Birth
• Stress

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitaliter Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	After completing the HRVB program (on average 3 weeks)
Primary	Feasibility: Drop-out	The ratio of drop out.	After completing the HRVB program (on average 3 weeks)
Primary	Feasibility: Number of Sessions Completed During Study	Compliance with study protocol regarding the number of sessions attended by the participants.	After completing the HRVB program (on average 3 weeks)
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.	After completing the HRVB program (on average 3 weeks)
Secondary	HRV: RMSDD	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.	Before and after completing the HRVB program (on average 3 weeks).
Secondary	HRV: HF	High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.	Before and after completing the HRVB program (on average 3 weeks).
Secondary	Stress	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.	Before and after completing the HRVB program (on average 3 weeks).
Secondary	PTSD	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.	Before and after completing the HRVB program (on average 3 weeks).
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.	Before and after completing the HRVB program (on average 3 weeks).
Secondary	Depression	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.	Before and after completing the HRVB program (on average 3 weeks).