NCT05866549

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

May 10, 2023

Last Update Submit

March 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prenatal Attachment Inventory

    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

  • Depression Anxiety Stress Scale- 21 (DASS 21)

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL
Other: Mindfulness-based Childbirth and Parenting Program

Control Group

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Cebeci Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Findik E, Yilmaz Sezer N, Aker MN, Badur D. The effects of the Mindfulness-Based Childbirth and Parenting Program (MBCP) on prenatal attachment, depression, stress, and anxiety in pregnant women: A randomized controlled trial. J Affect Disord. 2025 May 1;376:341-346. doi: 10.1016/j.jad.2025.02.030. Epub 2025 Feb 15.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

May 22, 2023

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations