Recruiting

Observational Study

Sponsor:

Nova Southeastern University

Code:

NCT06718907

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 21 - 37

Healthy Volunteers: Accepted

Interventions

Simulated stimuli

Stress Management

Study Details

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.

Conditions

Pregnancy

Study ID

NCT06718907

Start date

Dec 20, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 37

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Simulated stimuli

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

Stress Management

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

Primary outcome measure

  • Stress level change [ Time Frame: 4-8 weeks ]

Central Contacts and Locations

Central contacts

Gesulla Cavanaugh, PhD, MS, MPH

9542621980gcavanaugh@nova.edu

Locations

Nova Southeastern University

Recruiting

Davie, Florida, United States, 33314

Contacts

Gesulla Cavanaugh, PhD, MPH, MS

954-262-1980gcavanaugh@nova.edu

More Information

Sponsor

Nova Southeastern University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • stressors, chronic stress, pregnancy, stress regulation, stress management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2026-02-25.