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Mitigating Response to Stressors in Pregnant Women

Nova Southeastern University (NSU) logo

Nova Southeastern University (NSU)

Status

Enrolling

Conditions

Pregnancy

Treatments

Behavioral: Stress Management
Behavioral: Simulated stimuli

Study type

Interventional

Funder types

Other

Identifiers

NCT06718907
NSU 2023-231

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

21 to 37 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: in 24 weeks gestation or more

  • between 21 and 37 years of age

Exclusion Criteria:

  • in less than 24 weeks gestation
  • high risk pregnancies

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Stress Exposure and Management
Experimental group
Description:
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.
Treatment:
Behavioral: Simulated stimuli
Behavioral: Stress Management

Trial contacts and locations

1

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Central trial contact

Gesulla Cavanaugh, PhD, MS, MPH

Data sourced from clinicaltrials.gov

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