NCT06299397

Brief 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'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 14, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 1, 2024

Last Update Submit

March 9, 2024

Conditions

Keywords

humor as topicbreastfeedingbondingantenatalmotivation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maternal Attachment Scale

    3 month

Study Arms (2)

Breastfeeding-Humor group

EXPERIMENTAL

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.

Behavioral: breastfeeding - humor training

Control Group

SHAM COMPARATOR

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.

Other: Control Group

Interventions

Breastfeeding and humor-based practice will continue for 35-45 minutes, once a week for 2 weeks.

Breastfeeding-Humor 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.

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing pregnant in the primiparous period
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age,
  • Having a healthy pregnancy,
  • Being literate,
  • Being in the gestational week,
  • Being primiparous,
  • Not having any psychiatric diagnosis.

You may not qualify if:

  • Not having attended one of the trainings
  • incompletely filling out the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simge OZTURK

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Simge Ozturk, Ph.D

    Bartın Unıversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
After randomization was performed by a researcher independent of the study, it was decided by lottery method which group would be the experiment and which group would be the control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

June 14, 2023

Primary Completion

July 14, 2023

Study Completion

February 14, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations