- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06299397
Breastfeeding Education and Humor-Based Practices on Breastfeeding
March 9, 2024 updated by: Simge Ozturk, Inonu University
The Effect of Breastfeeding Education and Humor-Based Practices on Breastfeeding Motivation and Attachment in the Antenatal Period
The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment.
32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project.
It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week.
Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session.
The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place.
In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included.
The training program prepared for breastfeeding education will be applied to pregnant women.
Then, humor will be applied.
A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month.
Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Breastfeeding is the ideal source of nutrition for babies.
The World Health Organization (WHO) recommends continuing breastfeeding exclusively with breast milk for the first 6 months and with complementary foods for up to 3 years.
Breastfeeding is extremely effective on the health of the baby and mother.
The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment.
32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project.
It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week.
Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session.
The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place.
In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included.
The training program prepared for breastfeeding education will be applied to pregnant women.
Then, humor will be applied.
A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month.
Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
Study Type
Interventional
Enrollment (Actual)
64
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
-
-
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Bartin, Turkey, 74100
- Simge OZTURK
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-
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 over 18 years of age,
- Having a healthy pregnancy,
- Being literate,
- 32-36. Being in the gestational week,
- Being primiparous,
- Not having any psychiatric diagnosis.
Exclusion Criteria:
- Not having attended one of the trainings
- incompletely filling out the questionnaires
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breastfeeding-Humor group
32 pregnant women were included in the experimental group determined by randomization method.
Consent to participate in the study was obtained from these pregnant women.
After obtaining consent, a pre-test was conducted.
Afterwards, pregnant women were given breastfeeding education and humor practice.
The application was applied once a week, twice a week.
An interim test was administered 1 month after the application, and a final test was administered 3 months later.
|
Breastfeeding and humor-based practice will continue for 35-45 minutes, once a week for 2 weeks.
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Sham Comparator: Control Group
After randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study.
The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later.
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After randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study.
The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Motivation Scale
Time Frame: 3 month
|
The scale consists of 24 items and 5 sub-dimensions.
Subdimensions of the scale; They were determined as intrinsic motivation, integrated regulation, identified regulation, introjected regulation, and external regulation.
Scale items are rated between 'I strongly disagree' (1 point) and 'I strongly agree' (4 points).
The scale is a 4-point Likert type, and each item receives a score between 1 and 4. The total score of the scale is not calculated.
The score of the sub-dimensions is calculated by taking the average of the scale sub-dimension scores.
It has been stated that the higher the score received from the scale sub-dimension, the higher the motivation representing that sub-dimension
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Attachment Scale
Time Frame: 3 month
|
It is a 26-item 4-point Likert type scale, with each item ranging from "always" to "never".
Each item contains direct statements and is calculated as Always (a) = 4 points, Often (b) = 3 points, Sometimes (c) = 2 points and Never (d) = 1 point.
An overall score is obtained from the sum of all items.
A high score indicates high maternal attachment.
The lowest score obtained from the scale varies between 26 and the highest score 104.
The scale has no cut-off score.
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simge Ozturk, Ph.D, Bartın Unıversity
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)
June 14, 2023
Primary Completion (Actual)
July 14, 2023
Study Completion (Actual)
February 14, 2024
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 1, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Inonu-SBF-4
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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