NCT05573009

The Effect of Stress Reduction Program on Pregnancy Process and Mental Health in High Risk Pregnant Women

Completed NA Last updated 5 October 2023

What this trial tests

NA trial testing cognitive behavioral approach-based stress reduction program in Pregnancy, High Risk in 60 participants. Completed in 31 July 2023.

Timeline

1 March 2022

Primary endpoint
31 March 2023

31 July 2023

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	60
Start date	1 March 2022
Primary completion	31 March 2023
Estimated completion	31 July 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• cognitive behavioral approach-based stress reduction program

Conditions studied

• Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
• Depression, Postpartum — all drugs for Depression, Postpartum →
• Anxiety in Pregnancy — all drugs for Anxiety in Pregnancy →
• Stress Disorder — all drugs for Stress Disorder →

Sponsor

Istanbul University

Who can join

18 and older, female only, with Pregnancy, High Risk or Depression, Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Pregnancy and giving birth to an infant is a physiological process as well as it is also a transition of life, and a stressful period of time with a significance in the life of woman. This period is evaluated as a developmental crisis for the woman, and for her family.

High-risk pregnant women are at the forefront of the individuals who need to be supported the most during the transition to motherhood.The presence of a physiological, emotional and psychosocial condition that endanger the health and life of the pregnant and/or fetus and increases the risk of illness and death is defined as "high-risk pregnancy". Exposure to obstetric complications is known to be associated with the later development of psychiatric disorders.

In the literature review, it is seen that there are few studies in which CBT and mindfulness-based interventions are applied to reduce stress, anxiety and depression in risky or risk-free pregnant women. However, no CBT-based stress reduction program applied to high-risk pregnant women has been found in our country. A stress reduction program based on cognitive behavioral interventions during the transition to motherhood can contribute to the protection of maternal mental health and psychological well-being in pregnant women, and may help for healthy pregnancy and birth outcomes.

Research Aim This study was planned to examine the effect of cognitive behavioral approach-based stress reduction program on pregnancy process and maternal mental health to be applied to high-risk pregnant women.

Research Type The study was planned as an experimental study with a randomized control group including pre-test, post-test and follow-up measurements to examine the effect of "stress reduction program based on cognitive behavioral approach" on the maternal mental health, pregnancy, and childbirth process of the high risk pregnant women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.