Mitigating Response to Stressors in Pregnant Women

NCT ID: NCT06718907

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2026-12-31

Brief Summary

Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.

Detailed Description

Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.

Conditions

Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stress Exposure and Management

All pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection.

Group Type: EXPERIMENTAL

Simulated stimuli

Intervention Type: BEHAVIORAL

Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.

Stress Management

Intervention Type: BEHAVIORAL

Participants will practice stress management and stress reduction at home, independently.

Interventions

Simulated stimuli

Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.

Intervention Type: BEHAVIORAL

Stress Management

Participants will practice stress management and stress reduction at home, independently.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• between 21 and 37 years of age

Exclusion Criteria

• in less than 24 weeks gestation
• high risk pregnancies

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gesulla Cavanaugh, PhD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University

Davie, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gesulla Cavanaugh, PhD, MS, MPH

Role: CONTACT

gcavanaugh@nova.edu

9542621980

Facility Contacts

Gesulla Cavanaugh, PhD, MPH, MS

Role: primary

gcavanaugh@nova.edu

954-262-1980

Other Identifiers

NSU 2023-231

Identifier Type: -

Identifier Source: org_study_id