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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06299397
Other study ID # Inonu-SBF-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2023
Est. completion date February 14, 2024

Study information

Verified date March 2024
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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'.


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'.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date February 14, 2024
Est. primary completion date July 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
breastfeeding - humor training
Breastfeeding and humor-based practice will continue for 35-45 minutes, once a week for 2 weeks.
Other:
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.

Locations

Country Name City State
Turkey Simge OZTURK Bartin

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding Motivation Scale 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 Maternal Attachment Scale 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
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