Investigation of the Effect of Mindfulness-Based Stress Reduction Program on in Pregnant Women

NCT05804838 | Enrolling By Invitation

• 1 other identifier: Uskudar University ESagiroglu
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Mediation; Depression; Maternal-Fetal Relations

Keywords

depression; conscious awareness; midwifery; prenatal attachment; pregnancy

Outcome Measures

Primary Outcomes (4)

• Psychological well-being scale

  The reliability study, the cronbach alpha coefficient was determined as .80. Its consists of a single sub-dimension and 8 items. The items of the scale consist of an answer scale of (1) Strongly disagree, (2) Disagree, (3) Slightly disagree, (4) Undecided, (5) Slightly Agree, (6) Agree, (7) Strongly Agree. All items of the scale are expressed positively. The scores that can be obtained from the scale range from 8 to 56, and it is stated that the person with a high score has a certain psychological resource and power. The application time for each pregnant takes approximately 5 minutes.

  at inclusion

• Beck depression scale

  This scale is a 21-item self-assessment scale and measures depressive symptoms and characteristic approaches. It provides a four-point Likert-type measurement. Each item gets progressively increasing points between 0 and 3, and the total score is obtained by summing them up. Each item was given a score between 0 and 3, and the highest score that could be obtained from the scale was calculated as 63 and the lowest score as 0. A high score on the scale indicates that the severity or level of depression is high. The application time for each pregnant takes approximately 20 minutes.

  at inclusion

• Prenatal attachment scale

  It is a 15-item scale. High scores on the scale indicate high conscious awareness. It is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never). The application time for each pregnant takes approximately 25 minutes.

  at inclusion

• Conscious awareness scale

  Scale is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life. The Conscious Awareness Scale has a single factor structure and gives a single total score. High scores on the scale indicate high conscious awareness. The Conscious Awareness Scale is a 6-point Likert type scale (almost always, often, sometimes, rarely, quite rarely, almost never). The validity and reliability results of the Conscious Awareness Scale have shown that the Conscious Awareness Scale is a highly valid and reliable measurement tool. The internal consistency coefficient (coefficient alpha) of the scale is 0.82. The application time for each pregnant takes approximately 10 minutes.

  at inclusion

Secondary Outcomes (4)

• Psychological well-being scale

  At the end of the Mindfulness-Based Stress Reduction Program (week 8)

• Beck depression scale

  At the end of the Mindfulness-Based Stress Reduction Program (week 8)

• Prenatal attachment scale

  At the end of the Mindfulness-Based Stress Reduction Program (week 8)

• Conscious awareness scale

  At the end of the Mindfulness-Based Stress Reduction Program (week 8)

Other Outcomes (4)

• Psychological well-being scale

  At the end of the Mindfulness-Based Stress Reduction Program (at week 12)

• Beck depression scale

  At the end of the Mindfulness-Based Stress Reduction Program (at week 12)

• Prenatal attachment scale

  At the end of the Mindfulness-Based Stress Reduction Program (at week 12)

Study Arms (1)

Mindfulness Group

EXPERIMENTAL

Research 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 an obstacle to physical activity * Agreeing to participate in the 8-week MBSR training * Being able to use ZOOM Cloud Meetings program

Other: Mindfulness stress reduction program group

Interventions

Mindfulness stress reduction program group OTHER

Conscious Awareness Based Stress Reduction program will be applied to women in this group, which will last for 8 weeks. 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 pregnant women who make up the intervention group before the implementation of the Mindfulness-Based Stress Reduction program. The intervention group will receive 1 session per week. Each session will last 80 minutes. After completing the 8-week MBSR program, data collection forms will be re-applied to the pregnant women in the intervention group and posttest-1 measurements will be made. After the posttest-1 measurements, the pregnants in the intervention group will be given posttest-2 measurements of the pregnants in the intervention group, 1 month after the measurements.

Mindfulness Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: being a pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Istanbul Provincial Health Directorate Umraniye Training and Research Hospital

Istanbul, Umraniye, 11340168, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Negotiating; Depression

Condition Hierarchy (Ancestors)

Communication; Behavior; Behavioral Symptoms

Study Officials

• Yasemin Aydın Kartal, Ass.Prof.Dr

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Ebru Sağıroğlu, PhD.Stu.

  Uskudar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Since the study is a doctoral thesis, blinding cannot be done due to its nature.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 7, 2023
• Study Start: September 11, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)