The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment

NCT ID: NCT06316518

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pregnancy is a process in which physical and hormonal changes occur in the female body. During this period, women experience mood swings due to changes in hormonal and social roles. These changes may predispose some women to mental health problems. Due to physiological and psychological changes during pregnancy, pregnant women may experience some problems such as nausea, vomiting, fatigue, anxiety, stress and depression . It is important to show pregnant women that these are normal experiences and to adopt an accepting attitude towards these experiences.

Perceived stress during pregnancy can cause many negative effects on maternal and fetal health. Among the causes of perceived stress are being diagnosed with a risky pregnancy, the presence of danger symptoms during pregnancy, the occurrence of adverse conditions during pregnancy and uncertainties about the pregnancy process.

Birth self-efficacy is defined as the level of assurance that a mother can give birth by using her abilities successfully. Birth self-efficacy is a motivating factor for the mother to cope with childbirth. High self-efficacy can reduce fear of childbirth and lead to better birth outcomes.

Prenatal attachment is defined as the expectant mother's attachment to the fetus through her behavior during pregnancy, establishing a close relationship and interacting with it. Prenatal attachment is an important component of the concept of fetal protection with the mother's attitudes of recognizing, being with and protecting her baby. The bond between mother and fetus has a great impact on the social and emotional development of the baby. A significant part of the attachment between mother and fetus begins during pregnancy and increases within a month after birth.

Supportive interventions, when necessary, to reduce perceived stress in pregnant women are critical for the protection of women's overall health. One of the non-pharmacological interventions is a mindfulness-based stress reduction program. Due to the success of standardized mindfulness-based interventions, mindfulness-based interventions have rapidly spread in western psychology research and practice. Abdolalipour et al. In a systematic review and meta-analysis of ten studies in 2023, Abdolalipour et al. reported that mindfulness practice reduced fear of childbirth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups with a supportive care control groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness group

Primigravidas randomly assigned to the experimental group will be given web-based mindfulness-based stress reduction trainings after pre-tests are applied.

Group Type EXPERIMENTAL

mindfulness group

Intervention Type OTHER

In the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week.

control group

After the pre-tests were applied to the control group, routine nursing care will be given and post-test measurements will be made after 8 weeks.

Group Type ACTIVE_COMPARATOR

mindfulness group

Intervention Type OTHER

In the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mindfulness group

In the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Graduated from at least primary school
* Having a computer or a cell phone,
* Having access to the Internet,
* Being between the ages of 18-35,
* Being 18-24 weeks pregnant,
* Having a single healthy fetus,
* Being primigravida,
* Not having a risky pregnancy (such as placenta previa, preeclampsia, not having any systemic disease),
* Not participating in any childbirth preparation class
* Not having a neurological or psychiatric disease.

Exclusion Criteria

* Voluntary withdrawal from the study
* Failure to complete the 8-module training for any reason
* Interruption of internet access and inability to communicate
* Termination of pregnancy for any reason
* Non-participation in the trainings given in the experimental group
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

YILMAZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AIBU-HF-YS-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.