- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05866549
The Effect of The Mindfulness-based Childbirth and Parenting Program
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ankara University Cebeci Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
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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.
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No Intervention: Control Group
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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