The Effect of The Mindfulness-based Childbirth and Parenting Program

• Sponsor: Ezgi Findik (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05866549
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Other: Mindfulness-based Childbirth and Parenting Program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of The Mindfulness-based Childbirth and Parenting Program on Prenatal Attachment and Depression, Stress, Anxiety Levels of Pregnants
• Anticipated Study Start Date: May 22, 2023
• Anticipated Primary Completion Date: Aug 22, 2023
• Anticipated Study Completion Date: Aug 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group	Other: Mindfulness-based Childbirth and Parenting Program; 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

Outcome Measures

Primary Outcome Measures

1. Prenatal Attachment Inventory [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 increase in the score obtained by the pregnant indicates that the level of attachment also increases.

2. Depression Anxiety Stress Scale- 21 (DASS 21) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ezgi Findik

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ezgi Findik, Dr, Ankara University
• ClinicalTrials.gov Identifier: NCT05866549
• Other Study ID Numbers: 20/198
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 19, 2023