Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
Primary Purpose
Psychological Stress in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Stress in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women between 18-45 years old,Self-report
- Not smoking during pregnancy,Self-report
- Healthy pregnancy,Self-report
- 26 weeks ± 3 weeks gestation by time of enrollment,Self-report
- Delivering baby at CUMC- CHONY or Allen Pavilion,Self-report
- Receiving prenatal care,Self-report
Exclusion Criteria:
- Multi-fetal pregnancy, Selfreport
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2-adrenoceptor agonists), Selfreport
- Drinking alcohol or using recreational drugs during pregnancy, Selfreport
- Premature birth (before 37.5 weeks gestation)*, Medical record
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
No Intervention
No Intervention
Arm Label
Coached Intervention
Home Intervention
Control Group
Postpartum Only
Arm Description
Perform prenatal relaxation exercise in the lab with a coach and at home
Only perform relaxation exercise at home
Never performs relaxation routine, attends prenatal assessment sessions
Only attends visits postpartum, never receives prenatal assessments
Outcomes
Primary Outcome Measures
Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire
Improved level of mother-infant bonding as assessed by Postpartum Bonding Questionnaire
Secondary Outcome Measures
Change in Maternal Stress Level during Pregnancy as assessed by Perceived Stress Scale
Reduction in stress as operationalized through Perceived Stress Scale
Full Information
NCT ID
NCT02943083
First Posted
October 13, 2016
Last Updated
July 29, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT02943083
Brief Title
Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
Official Title
Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Johnson & Johnson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aims of this study are to determine if:
during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") can, acutely, reduce maternal stress and affect the fetus (in terms of movement, changes in heart rate and heart rate variability);
a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") during pregnancy can have an effect on mitochondria functioning in the placenta through reducing maternal stress during pregnancy (based on our recent findings (Monk et al, 2016));
the scent will come to function as a conditioned stimulus such that exposure to the scent postpartum will induce greater maternal relaxation, which will have an effect on the mother-infant interaction and infant physiology;
prenatal maternal exposure to scent combined with abdominal touch will lead to mothers' increased likelihood of utilizing infant massage with a lotion of the same scent postpartum;
the prenatal ritual and the increased likelihood of engaging in infant massage will lead to a maternal perception of greater mother-infant bonding, attachment and parenting efficacy, and improved maternal mood;
the prenatal ritual and the increased likelihood of engaging in infant massage will lead to improved performance on the conjugate reinforcement paradigm conditioning task administered to infants at 4 months of age
Detailed Description
Some women will randomly be assigned to perform the prenatal relaxation ritual both in our lab and at home (Coached Intervention (CI)); some to make prenatal visits to the lab but perform the prenatal relaxation ritual at home only (Home Intervention (HI)); and some to make prenatal visits to the lab but never to perform the prenatal relaxation ritual (Control Group (CG)). In addition, a fourth group of participants will participate in postpartum sessions only (Postpartum Only Group (PO)); the only prenatal experience these participants will have in the laboratory will be the informed consent session. Participants in all four groups (CI, HI, CG, PO) will participate in an informed consent and demographic information session prenatally, during which demographic information and medical history will be collected. At the informed consent and demographic information session, women who participate in prenatal sessions (those in CI, HI and CG) will smell three scent sticks and select their favorite scent. Women in the relaxation ritual groups (those in CI and HI) will utilize the scent in the relaxation ritual during pregnancy. Women in the CG will not be exposed to the scent again until the postpartum period (as detailed in the description of postpartum sessions, below). After the informed consent session, women who participate in prenatal sessions (those in CI, HI and CG) will come into the lab three times for the prenatal sessions, during which participants will be administered questionnaires about background information, moods and stress; collect hair samples for analysis of the stress hormone cortisol; collect blood and saliva samples for analysis of the hormone oxytocin, which plays a role in social interaction, bonding and lactation; and conduct fetal sessions to simultaneously collect maternal and fetal heart rate, as well as maternal blood pressure and respiration and fetal movement. Women in the group that performs the relaxation ritual in the lab (CI) will perform the ritual during the fetal sessions; this will allow assessment of any acute affects of the ritual on mom and fetus. In order to assess if the relaxation ritual during pregnancy can have an effect on mitochondria functioning in the placenta, placentas will be collected from all participants post-delivery and stored for future analyses.
All women will participate in a postpartum session in the hospital within 36 hours of birth. At this session, women in the PO group will have the opportunity to smell the same scent sticks that the other groups smelled prenatally, and select a favorite scent. All women will be given a scented lotion, matching the scent participants were exposed to either prenatally (CI and HI), that participants chose prenatally for postpartum use (CG) or that participants had just selected postpartum (PO). All women will apply the scented lotion and pick up their babies at this session. During this holding period, the investigators will monitor mother and baby heart rate and respiration and baby brain activity via EEG to assess maternal and infant relaxation. Afterwards, all women will be given information on how to use the lotion to give a gentle infant massage.
All dyads will also participate in a 6-week taped diapering and lotion session; the tape will be coded for quality of mother-infant interaction to assess dyadic affect and bonding. Participants will also participate in a session 4-months postpartum where infants engage in a neurocognitive test that assesses memory through a kicking task (conjugate reinforcement paradigm conditioning task). Women will answer questionnaires about their moods, how participants feel about their babies and their babies' daily routines at both of these sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress in Pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coached Intervention
Arm Type
Experimental
Arm Description
Perform prenatal relaxation exercise in the lab with a coach and at home
Arm Title
Home Intervention
Arm Type
Active Comparator
Arm Description
Only perform relaxation exercise at home
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Never performs relaxation routine, attends prenatal assessment sessions
Arm Title
Postpartum Only
Arm Type
No Intervention
Arm Description
Only attends visits postpartum, never receives prenatal assessments
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Exercise
Intervention Description
Groups receiving the intervention will be asked to engage in the relaxation protocol every day. Participants will be asked to continue practicing the relaxation protocol for the remainder of their pregnancy. Participants will be instructed to listen to the 7 minute guided muscle relaxation tape and engage in the 3 minute abdominal touch routine in the presence of the scent stick. Participants will be provided with a scent stick of their selected scent to take home. For the duration of the study, participants will be loaned standard headphones and an iPod Touch that contains only the guided progressive muscle relaxation audio recording to facilitate this at-home protocol.
Primary Outcome Measure Information:
Title
Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire
Description
Improved level of mother-infant bonding as assessed by Postpartum Bonding Questionnaire
Time Frame
6 weeks to 4 months postpartum
Secondary Outcome Measure Information:
Title
Change in Maternal Stress Level during Pregnancy as assessed by Perceived Stress Scale
Description
Reduction in stress as operationalized through Perceived Stress Scale
Time Frame
Change over time from 24 weeks gestation to 36 weeks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women between 18-45 years old,Self-report
Not smoking during pregnancy,Self-report
Healthy pregnancy,Self-report
26 weeks ± 3 weeks gestation by time of enrollment,Self-report
Delivering baby at CUMC- CHONY or Allen Pavilion,Self-report
Receiving prenatal care,Self-report
Exclusion Criteria:
Multi-fetal pregnancy, Selfreport
Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2-adrenoceptor agonists), Selfreport
Drinking alcohol or using recreational drugs during pregnancy, Selfreport
Premature birth (before 37.5 weeks gestation)*, Medical record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Monk, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
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