Stress Management for Pregnancy

Overseen By Gesulla Cavanaugh, PhD, MS, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Less than 24 weeks, high risk

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stress affects pregnant women and to find effective ways to manage it. Participants will learn stress management techniques, such as breathing exercises and listening to music, to reduce stress. The trial seeks pregnant women who are at least 24 weeks along and experiencing stress in their daily lives. This research could help identify better ways to support pregnant women dealing with stress. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance stress management for pregnant women.

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 prior data suggests that these stress management techniques are safe for pregnant women?

Research shows that stress management techniques, such as breathing exercises and listening to music, are generally safe and beneficial for pregnant women. These methods are non-invasive, as they don't involve surgery or medication.

Studies have found that stress reduction programs can support mental health during pregnancy. Although specific safety data for these techniques in pregnant women is lacking, they have been widely used without reports of harm. These techniques are generally well-tolerated because they are gentle and focus on relaxation.

It is always important to consult a healthcare provider before starting any new program, especially during pregnancy, to ensure it is safe for the specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this stress management technique for pregnant individuals because it offers a simple, self-administered approach to reducing stress, which is crucial during pregnancy. Unlike traditional methods that may involve medication or professional therapy, this treatment allows participants to independently practice techniques like deep breathing and music listening at home. This empowers pregnant individuals to actively manage their stress in a natural and accessible way, potentially improving both maternal and fetal health outcomes.

What evidence suggests that stress management is effective for reducing stress-induced pregnancy complications?

Research has shown that techniques to reduce stress during pregnancy can be very helpful. Certain methods, for example, can cut the risk of early birth in half. In this trial, participants will experience mild stress and then practice stress management techniques, such as breathing exercises and listening to music, to lower stress levels and improve mental health. Reducing stress is important because it can affect the health of both the mother and the baby. Overall, these approaches appear to make the pregnancy experience healthier and more positive. ^{2 6 7 8 9}

Who Is on the Research Team?

Gesulla Cavanaugh, PhD, MPH, MS

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Simulated stimuli
• Stress Management

Trial Overview The 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.

How Is the Trial Designed?

Group I: Stress Exposure and Management Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Published Research Related to This Trial

Recent research highlights the significant impact of prenatal stress and anxiety on maternal, fetal, and neonatal health outcomes, indicating a need for better understanding and management of these stressors during pregnancy.

The review discusses limited but available treatment measures for addressing prenatal stress and anxiety, along with recommendations for policy development and future research directions to improve reproductive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of anxiety, stress, and psychosocial development to reproductive health. Lederman, RP.[2005]

Provider-based stress-reducing interventions during pregnancy, such as skills-building, mindfulness, behavioral therapy, and group support, can improve mood and reduce stress among pregnant individuals, particularly those from marginalized communities.

The review analyzed 23 studies and found that while the overall effectiveness of these interventions varies, group-based therapies that combine multiple approaches tend to be more beneficial in addressing maternal stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. Moore, N., Abouhala, S., Maleki, P., et al.[2023]

Nearly 90% of pregnant women in the U.S. take medications, but there is a significant lack of comprehensive safety data regarding these medications, which complicates informed discussions between healthcare providers and patients.

Current resources, like package inserts, often rely on incomplete data and animal studies, highlighting the need for better access to up-to-date information and the importance of pregnancy registries to gather more safety data on medication use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Safety During Pregnancy: Improving Evidence-Based Practice. Sinclair, SM., Miller, RK., Chambers, C., et al.[2022]

This systematic review aimed to evaluate the effectiveness of non-medical interventions, like counseling, to reduce stress in pregnant women with a history of miscarriage, but ultimately found no randomized controlled trials (RCTs) that met the inclusion criteria.

While previous studies suggest that support and psychological interventions may benefit the mental health of pregnant women after miscarriage, the lack of suitable RCTs highlights a significant gap in research, indicating a need for targeted studies to identify effective strategies for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. San Lazaro Campillo, I., Meaney, S., McNamara, K., et al.[2022]

Even low levels of alcohol exposure during pregnancy can harm fetal development, highlighting the need to identify pregnant women who consume alcohol.

Researchers have created effective and simple screening tools that can quickly assess alcohol use in pregnant women, making them valuable preventive measures when used with proper follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-screening instruments for pregnant women. Chang, G.[2023]

In a study involving 25 bereaved mothers, most reported that consenting to an autopsy for their stillborn baby provided them with peace of mind and helped reduce feelings of blame.

The results of the autopsy were generally seen as beneficial for coping with the loss, although some participants who struggled to understand the results had negative reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bereaved mothers' attitudes regarding autopsy of their stillborn baby. Human, M., Goldstein, RD., Groenewald, CA., et al.[2022]

Maternal emotional health during pregnancy, including depression and anxiety, significantly impacts child development, contributing to 10-15% of emotional and behavioral issues in children.

The Nurse Family Partnership is the only proven intervention that begins during pregnancy and offers long-term benefits for child behavior, highlighting the need for better detection and treatment of maternal mental health issues in obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal depression, anxiety and stress during pregnancy and child outcome; what needs to be done. Glover, V.[2022]

Medication use during pregnancy is common, but there is limited safety data for most medications, making observational studies crucial for understanding their risks and benefits.

The article emphasizes the importance of using diverse data sources, such as pregnancy registries and electronic health records, to improve the quality of evidence on medication safety in pregnancy and suggests strategies for enhancing study designs to better communicate risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research. Wood, ME., Andrade, SE., Toh, S.[2023]

Mind-body interventions, such as imagery and autogenic training, may help reduce anxiety in pregnant women, with some studies showing positive effects during labor and in the postpartum period.

While there is some evidence supporting the effectiveness of these interventions for managing anxiety during pregnancy, the studies had limitations, including lack of blinding and insufficient randomization details, indicating that more rigorous research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions during pregnancy for preventing or treating women's anxiety. Marc, I., Toureche, N., Ernst, E., et al.[2022]

A study involving 60 pregnant women in their second trimester showed that a 6-week relaxation program significantly reduced perceived stress and increased their sense of control over their situation.

The relaxation techniques, including breathing exercises and progressive muscle relaxation, provide a promising non-drug intervention to improve mental well-being during pregnancy, although further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of a stress management programme during pregnancy. Tragea, C., Chrousos, GP., Alexopoulos, EC., et al.[2022]

The study involving 33 fetuses found that maternal relaxation techniques, particularly guided imagery (GI), positively influenced fetal behavior, with increased long-term heart rate variation compared to a control group.

Women practicing progressive muscle relaxation (PMR) exhibited more uterine activity than those using GI or the control group, suggesting that different relaxation methods may have varying effects on maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. Fink, NS., Urech, C., Isabel, F., et al.[2011]

A comprehensive analysis identified 80 prescription medications of greatest concern during pregnancy, primarily including antineoplastic agents, ACE inhibitors, angiotensin II receptor antagonists, and anticonvulsants, based on data from 1,186 medications.

The study utilized advanced prediction models to categorize medications as 'high' risk, providing healthcare providers with an evidence-based tool to better counsel pregnant women on medication safety and the importance of weighing risks and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Supervised Learning Methods to Develop a List of Prescription Medications of Greatest Concern during Pregnancy. Ailes, EC., Zimmerman, J., Lind, JN., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5052760/

Effects of prenatal stress on pregnancy and human ... A growing body of research shows that prenatal stress can have significant effects on pregnancy, maternal health and human development across the lifespan.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1049386723000105

The Efficacy of Provider-Based Prenatal Interventions to ... This review evaluates the effectiveness of prenatal provider-based interventions that reduce stress for pregnant people.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05573009

The Effect of Stress Reduction Program on Pregnancy ... Research Aim This study was planned to examine the effect of cognitive behavioral approach-based stress reduction program on pregnancy process and maternal ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/0167482X.2023.2281238

Full article: Stress-reducing interventions in pregnancy for ... Our results indicate that stress-reducing interventions significantly reduce the incidence of PTB in a low-risk obstetric population. With a RR for PTB of 0.50 ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278432

Effects of relaxation interventions during pregnancy on ... We found consistent evidence for beneficial effects of relaxation interventions in reducing maternal stress, improving mental health, and some evidence for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10643752/

Effects of Prenatal Stress on Behavior, Cognition, and ... This comprehensive review explores the intricate relationship between prenatal stress and its effects on behaviour, cognition, and psychopathology.

7. withpower.com withpower.com/trial/phase-pregnant-state-11-2024-c1d43

Stress Management for Pregnancy The research articles provided do not contain specific safety data on stress management techniques for pregnant women. However, they highlight the general lack ...

8. research.aota.org research.aota.org/ajot/article/79/6/7906205030/28466/Psychosocial-Occupational-Therapy-Interventions

Psychosocial Occupational Therapy Interventions for High ... Effective psychosocial support during a high-risk pregnancy has the potential to reduce stress, improve coping strategies, and enhance mother– ...

9. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-025-03237-3

Relationship between prenatal anxiety, depression ... Existing studies have confirmed that depression, anxiety, and stress often coexist and interweave during pregnancy, forming a vicious cycle [13] ...