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Relaxation Exercise for Prenatal Stress

N/A

Waitlist Available

Led By Catherine Monk, Ph.D.

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks to 4 months postpartum

Awards & highlights

Study Summary

This trial will test whether a relaxation ritual involving a pleasing scent can reduce maternal stress and affect the fetus during pregnancy. If successful, the scent will be used postpartum to help with mother-infant bonding, attachment, and parenting efficacy.

Eligible Conditions

Prenatal Stress

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks to 4 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks to 4 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks to 4 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire

Secondary outcome measures

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Coached InterventionExperimental Treatment1 Intervention

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

Group II: Control GroupActive Control1 Intervention

Never performs relaxation routine, attends prenatal assessment sessions

Group III: Postpartum OnlyActive Control1 Intervention

Only attends visits postpartum, never receives prenatal assessments

Group IV: Home InterventionActive Control1 Intervention

Only perform relaxation exercise at home

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relaxation Exercise

2023

N/A

~170

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Who is running the clinical trial?

Johnson & JohnsonIndustry Sponsor

105 Previous Clinical Trials

26,303 Total Patients Enrolled

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,801 Total Patients Enrolled

Catherine Monk, Ph.D.Principal InvestigatorColumbia University

2 Previous Clinical Trials

276 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots to join this medical experiment?

"The information hosted on clinicaltrials.gov indicates that this particular medical trial is no longer enrolling participants. This research project was first announced in October 2016 and the most recent update occured April 2022. Although this investigation has completed recruitment, there are 107 other studies actively seeking test subjects at present."

Answered by AI

Does this research involve minors?

"In compliance with the study's entry requirements, participants must be at least 18 years old and no older than 45."

Answered by AI

Who would be an eligible participant for this research study?

"This trial, which is aiming to recruit a total of 106 individuals, requires that all participants suffer from psychological distress during pregnancy and must be between 18 and 45 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy

Elizabeth Werner 2016. "Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02943083.