Clinical trial NCT05804838: Investigation of the Effect of Mindfulness-Based Stress Reduction Program on in Pregnant Women
Official title: Investigation of the Effect of Mindfulness-Based Stress Reduction Program on Depression, Psychological Well-Being and Prenatal Attachment in Pregnant Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Mediation
Depression
Maternal-Fetal Relations
Keywords: depression
conscious awareness
midwifery
prenatal attachment
pregnancy
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2023-04-07
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled treatments will be carried out in a design. These randomized controlled restrictions should be followed by the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline controls. The study will consist of an Intervention and a control group.
Primary purpose: TREATMENT

Brief summary: This study was planned to examine the effects of the Mindfulness-Based Stress Reduction Program, which is one of the popular concepts of the 21st century, on depression, psychological well-being and prenatal attachment, which are likely to occur as a result of increased stress during an important period that requires adjustment as a result of physical, mental and cognitive changes during pregnancy. It will be conducted in a randomized parallel controlled experimental design type using Consolidated Standards of Reporting Trials (CONSORT) guidelines. It is planned to be carried out with the ZOOM Cloud Meetings program, which is an online education platform, with pregnant women who apply to the Health Sciences University Ümraniye Training and Research Hospital pregnancy polyclinic in the Ümraniye district of Istanbul. The universe of the research will be the pregnant women who applied to the Health Sciences University Ümraniye Training and Research Hospital pregnant outpatient clinic. Primiparous pregnant women who meet the inclusion criteria and willingly agree to participate in the study will be included in the study. 54 people in the intervention group, 54 people in the control group, and a total of 108 people will be taken.

While the Conscious Awareness-Based Stress Reduction Program adapted for pregnant women will be applied to the intervention group, routine follow-up will be applied to the control group within the scope of the outpatient clinic follow-up of the relevant institution. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale and Conscious Awareness Scale will be administered to the participants included in the study. As a result of the findings, the discussion and results of the study will be written.

Detailed description: Studies with a high level of evidence evaluating the effectiveness of mindfulness-based practices in obstetrics are limited. It is stated that little is known about the effects of mindfulness-based interventions, which is one of the non-pharmacological methods in the prenatal period, on pregnant women. In a limited number of studies, it is noted that mindfulness-based approaches used in the prenatal period increase the level of awareness by reducing depression, anxiety and anxiety levels. Studies on how to improve the importance of depression, psychological well-being and the bond established with the fetus during pregnancy have been limited to routine birth preparation trainings.

With the importance of living in the moment, focusing on the moment and staying in the moment in the 21st century, mindfulness programs increase the quality of instant life. Especially during the pregnancy period, where many changes are experienced, the studies that adapted the Mindfulness-Based Stress Reduction Program were quite inadequate.

In the literature, many mindfulness-based programs, including the mindfulness-based stress reduction program, have been used in health areas outside the field of midwifery and evidence-based benefits have been demonstrated. However, there is no study examining depression, psychological well-being, and prenatal attachment levels with mindfulness-based stress reduction. The design of the study gives originality to the study with this aspect. In line with the results of the research, in case of methods/methods with which depression, psychological well-being and prenatal attachment efficiency can be determined during pregnancy, compliance with the pregnancy process, reduction in pregnancy complaints, less need for medical intervention and increase in the number of spontaneous vaginal deliveries in line with the preference of the woman in the delivery room, postpartum mother-infant attachment, Considering that there will be an increase in compliance with the breastfeeding process and newborn care, it can be presented as an alternative method in pregnant training in the preparation process for childbirth.

Eligibility criteria: Inclusion Criteria:

* Being between 20-35 years old
* Being her first pregnancy
* Being between 13 and 24 weeks of gestation
* Having applied to the pregnant outpatient clinic where the research will be conducted.
* Not having a hearing-visual impairment
* Ability to read and write Turkish
* Volunteering to participate in the research
* Not having a diagnosis that would constitute a physical activity disability.
* Agreeing to participate in the 8-week MBSR training
* Being able to use ZOOM Cloud Meetings program

Exclusion Criteria:

* Being diagnosed with acute/chronic disease during pregnancy
* Having a diagnosis of mental illness in the pregnant
* Multiple pregnancy
* Having participated in any awareness-based training program in the last 1 year

Primary outcomes:
measure: Psychological well-being scale
timeFrame: at inclusion
measure: Beck depression scale
timeFrame: at inclusion
measure: Prenatal attachment scale
timeFrame: at inclusion
measure: Conscious awareness scale
timeFrame: at inclusion
Secondary outcomes:
measure: Psychological well-being scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
measure: Beck depression scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
measure: Prenatal attachment scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
measure: Conscious awareness scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Other outcomes:
measure: Psychological well-being scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (at week 12)
measure: Beck depression scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (at week 12)
measure: Prenatal attachment scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (at week 12)
measure: Conscious awareness scale
timeFrame: At the end of the Mindfulness-Based Stress Reduction Program (at week 12)
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Provincial Health Directorate Umraniye Training and Research Hospital
state: Umraniye
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Yasemin Aydın Kartal, Ass.Prof.Dr
role: STUDY_DIRECTOR
affiliation: Uskudar University
name: Ebru Sağıroğlu, PhD.Stu.
role: PRINCIPAL_INVESTIGATOR
References: