Stress Management for Pregnancy
Recruiting in Palo Alto (17 mi)
Overseen byGesulla Cavanaugh, PhD, MPH, MS
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Southeastern University
Disqualifiers: Less than 24 weeks, high risk
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Simulated stimuli, Stress Management, Stress Reduction, Anxiety Management, Prenatal Stress Intervention for managing stress during pregnancy?
Is stress management safe for pregnant women?
How is the Stress Management treatment for pregnancy different from other treatments?
Stress Management for pregnancy is unique because it focuses on non-drug approaches like mind-body interventions, which are designed to reduce anxiety and stress without medication. This is particularly important during pregnancy, as it avoids potential side effects of drugs and addresses emotional well-being, which is often overlooked in prenatal care.1231112
Eligibility Criteria
This trial is for pregnant women who are at least 24 weeks into their pregnancy and aged between 21 to 37 years. It's not suitable for those less than 24 weeks pregnant or with high-risk pregnancies.Inclusion Criteria
In 24 weeks gestation or more
I am between 21 and 37 years old.
Exclusion Criteria
In less than 24 weeks gestation
High risk pregnancies
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Stress Exposure and Management
Participants are exposed to a mild stressful stimulus and a relaxant to record physiological responses, followed by practicing stress management techniques at home for one week.
1 week
1 visit (in-person) for initial data collection
Follow-up
Participants are monitored for changes in stress levels as assessed by salivary cortisol levels.
4-8 weeks
Treatment Details
Interventions
- Simulated stimuli (Behavioral Intervention)
- Stress Management (Behavioral Intervention)
Trial OverviewThe study investigates how stress management techniques and simulated stimuli can help mitigate the effects of chronic stress in pregnant women, aiming to improve prenatal care and reduce complications.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stress Exposure and ManagementExperimental Treatment2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nova Southeastern UniversityDavie, FL
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Who Is Running the Clinical Trial?
Nova Southeastern UniversityLead Sponsor
References
The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. [2023]Exposure to stress during the prenatal period is often associated with adverse maternal and neonatal health outcomes and is increasing in prevalence in the United States. Health care providers play a crucial role in addressing and mitigating this stress, but there is a lack of consensus regarding effective interventions. This review evaluates the effectiveness of prenatal provider-based interventions that reduce stress for pregnant people, especially those who are disproportionately affected by stress.
Fetal response to abbreviated relaxation techniques. A randomized controlled study. [2011]stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome.
Maternal depression, anxiety and stress during pregnancy and child outcome; what needs to be done. [2022]Care for the emotional state of pregnant women remains a neglected aspect of obstetric medicine. Many prospective studies have shown that, if a mother is depressed, anxious, or stressed while pregnant, this increases the risk for her child having a wide range of adverse outcomes, including emotional problems, symptoms of attention deficit hyperactivity disorder, or impaired cognitive development. Although genetics and postnatal care clearly affect these outcomes, evidence for an additional prenatal causal component is substantial. Prenatal anxiety or depression may contribute 10-15% of the attributable load for emotional and behavioural outcomes. The Nurse Family Partnership remains the only intervention that starts in pregnancy and has been shown to have long-term benefits for the behaviour of the child. Several other interventions, however, are likely to be helpful. Depression, anxiety, and stress during pregnancy are frequently undetected by health professionals, and untreated. Programmes to help with this should eventually improve child outcome.
A randomized controlled trial of the effects of a stress management programme during pregnancy. [2022]Prenatal maternal stress is associated with adverse birth outcomes. Relaxation techniques might be effective in reducing stress during that period. The purpose of this study was to evaluate the effects of applied relaxation in reducing anxiety and stress in pregnant women in their second trimester, as well as raising their sense of control. Also we expected to see a difference in some lifestyle factors associated with stress. A randomized control trial with a prospective pretest-posttest experimental design was used.
Psychological and support interventions to reduce levels of stress, anxiety or depression on women's subsequent pregnancy with a history of miscarriage: an empty systematic review. [2022]The aim of this systematic review was to assess the effect of interventions to reduce stress in pregnant women with a history of miscarriage.
Medication Safety During Pregnancy: Improving Evidence-Based Practice. [2022]Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy.
Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research. [2023]Medication use in pregnancy is common, but information about the safety of most medications in pregnant women or their infants is limited. In the absence of data from randomized clinical trials to guide decisions made by regulators, clinicians, and patients, we often have to rely on well-designed observational studies to generate valid evidence about the benefits and risks of medications in pregnancy. Spontaneous reporting, primary case-control and cohort studies, pregnancy exposure registries, and electronic health data have been used extensively for studying medication safety in pregnancy. This article discusses these data sources, their strengths and limitations, and possible strategies and approaches to mitigating limitations when planning studies or interpreting findings from the literature. Strategies discussed include combining data sources across institutional or national borders, developing and using more sophisticated study designs, and taking advantage of existing analytic methods for more complex data structures, such as time-varying exposure or unmeasured confounding. Finally, we make recommendations for study designs that aid in better risk-related communication.
Alcohol-screening instruments for pregnant women. [2023]According to new studies, even low levels of prenatal alcohol exposure can negatively affect the developing fetus, thereby increasing the importance of identifying women who drink during pregnancy. In response, researchers have developed several simple alcohol-screening instruments for use with pregnant women. These instruments, which can be administered quickly and easily, have been evaluated and found to be effective. Because of the potential adverse consequences of prenatal alcohol exposure, short screening questionnaires are worthwhile preventive measures when combined with appropriate followup.
Using Supervised Learning Methods to Develop a List of Prescription Medications of Greatest Concern during Pregnancy. [2021]Women and healthcare providers lack adequate information on medication safety during pregnancy. While resources describing fetal risk are available, information is provided in multiple locations, often with subjective assessments of available data. We developed a list of medications of greatest concern during pregnancy to help healthcare providers counsel reproductive-aged and pregnant women.
Bereaved mothers' attitudes regarding autopsy of their stillborn baby. [2022]Here we present additional information from the Safe Passage Study, where the effect of alcohol exposure during pregnancy on sudden infant death syndrome and stillbirth was investigated.
Mind-body interventions during pregnancy for preventing or treating women's anxiety. [2022]Anxiety during pregnancy is a common problem. Anxiety and stress could have consequences on the course of the pregnancy and the later development of the child. Anxiety responds well to treatments such as cognitive behavioral therapy and/or medication. Non-pharmacological interventions such as mind-body interventions, known to decrease anxiety in several clinical situations, might be offered for treating and preventing anxiety during pregnancy.
Relationship of anxiety, stress, and psychosocial development to reproductive health. [2005]In this review of articles on prenatal stress, anxiety, development, and reproductive health outcomes in pregnancy, the focus is on recent research in which the relationships among the major types of stressors, anxiety, and development, on the one hand, and maternal, fetal, and neonatal problems or complications, on the other hand, were examined. Available and effective treatment measures, although limited, are introduced and discussed at length in a follow-up article. Recommendations for policy development based on current research and treatment methods and directions for future research and treatment studies are presented in a third article.