NCT02943083

Brief Summary

The aims of this study are to determine if:

  1. 1.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);
  2. 2.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));
  3. 3.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;
  4. 4.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;
  5. 5.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;
  6. 6.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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

October 13, 2016

Last Update Submit

July 29, 2023

Conditions

Psychological Stress in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire

    Improved level of mother-infant bonding as assessed by Postpartum Bonding Questionnaire

    6 weeks to 4 months postpartum

Secondary Outcomes (1)

  • Change in Maternal Stress Level during Pregnancy as assessed by Perceived Stress Scale

    Change over time from 24 weeks gestation to 36 weeks gestation

Study Arms (4)

Coached Intervention

EXPERIMENTAL

Perform prenatal relaxation exercise in the lab with a coach and at home

Behavioral: Relaxation Exercise

Home Intervention

ACTIVE COMPARATOR

Only perform relaxation exercise at home

Behavioral: Relaxation Exercise

Control Group

NO INTERVENTION

Never performs relaxation routine, attends prenatal assessment sessions

Postpartum Only

NO INTERVENTION

Only attends visits postpartum, never receives prenatal assessments

Interventions

Relaxation ExerciseBEHAVIORAL

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.

Coached InterventionHome Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women between 18-45 years old,Self-report
  • Not smoking during pregnancy,Self-report
  • Healthy pregnancy,Self-report
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Catherine Monk, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Behavioral Medicine (in Psychiatry) at CUMC

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 24, 2016

Study Start

October 1, 2016

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)