The Effect of The Mindfulness-based Childbirth and Parenting Program

March 5, 2024 updated by: Ezgi Findik

The Effect of The Mindfulness-based Childbirth and Parenting Program on Prenatal Attachment and Depression, Stress, Anxiety Levels of Pregnants

The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants.

The study will be carried out in two different groups. After the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. The random distribution of pregnants to the study groups will be carried out random. The following applications will be made to the groups.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Ankara University Cebeci Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being at 20-30 weeks of gestation
  • Being nulliparous

Exclusion Criteria:

  • History of psychiatric illness
  • Follow-up in the risky pregnancy clinic
  • Not completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Mindfulness-based childbirth and parenting program will be applied to individuals in this group. The program consists of nine sessions, eight of which will take place during pregnancy. Sessions planned during pregnancy will be held once a week, lasting 8 weeks.
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scale- 21 (DASS 21)
Time Frame: immediately after participants are assigned to groups and eight weeks later
In this scale (DASS-21), there are 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert Type Scale; 0 -3. Depression, anxiety and stress scores are measured by summing the scores of the related items. A minimum of 0 and a maximum of 21 points can be obtained in each dimension.
immediately after participants are assigned to groups and eight weeks later
Prenatal Attachment Inventory
Time Frame: immediately after participants are assigned to groups and eight weeks later
The scale, which is a four-point Likert-type scale, consists of 21 items. A minimum of 21 and a maximum of 84 points can be obtained from the scale. The change in the score obtained by the pregnant indicates that the level of attachment also increases.
immediately after participants are assigned to groups and eight weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20/198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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