NCT05735821

Brief Summary

The study was planned as a randomized controlled study to evaluate the effectiveness of breastfeeding behavior development training using Video and Simulator, given to mothers whose babies are in the neonatal intensive care unit and who are staying in the mother's guesthouse. As soon as the mothers who are separated from their babies and who have breastfeeding barriers come together with their babies and the breastfeeding barrier is lifted, to enable them to start breastfeeding effectively the effectiveness of the training, which will be given by applying 2 different methods based on the IMB (Knowledge, Motivation, Behavioral Skills) model will be evaluated. The aim of the training is to develop breastfeeding behavior in mothers and to ensure a secure attachment between mother and baby. (The research will be conducted in a randomized controlled trial model with a pretest-posttest control group.)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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 17, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

December 28, 2022

Last Update Submit

February 21, 2023

Conditions

Keywords

Mother HotelBreastfeeding EducationVideo and Breastfeeding SimulatorIMB ModelMaternal Attachment

Outcome Measures

Primary Outcomes (8)

  • In education groups; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire

    31 questions were created by the researcher by scanning the literature on the subject. The questions included women's socio-demographic characteristics, obstetric histories and newborn information.

    at admission

  • In education groups; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

    The minimum score to be obtained from the breastfeeding self-efficacy scale is 14, and the maximum score is 70. A high score indicates high breastfeeding self-efficacy.

    at admission

  • In education groups; Measuring the bond between mother and baby with the Maternal Attachment Scale

    The lowest score that can be obtained from the Maternal Attachment Scale is 26, and the highest score is 104. The Highest Score Indicates High Maternal Attachment.

    at admission

  • In education groups; Determining the Percentage of the Number of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding

    The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.

    at admission

  • In the control group; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire

    31 questions were created by the researcher by scanning the literature on the subject. The questions included women's socio-demographic characteristics, obstetric histories and newborn information.

    at admission

  • In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

    The minimum score to be obtained from the breastfeeding self-efficacy scale is 14, and the maximum score is 70. A high score indicates high breastfeeding self-efficacy.

    at admission

  • In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale

    The lowest score that can be obtained from the Maternal Attachment Scale is 26, and the highest score is 104. The Highest Score Indicates High Maternal Attachment.

    at admission

  • In the control group; Determining the Percentage of the Number of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding

    The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.

    at admission,

Secondary Outcomes (6)

  • In education groups; Evaluation of Breastfeeding Efficiency with the Breastfeeding Self-Efficacy Scale-Short Form after the training given with the video and breastfeeding simulator

    1 week after training and 1 month after retraining

  • In education groups; Measuring the bond between mother and baby with the Mother Attachment Scale after the training given with the video and breastfeeding simulator

    1 week after training and 1 month after retraining

  • In education groups; Determining the Rate of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding after the training given with the video and breastfeeding simulator

    1 week after training and 1 month after retraining

  • In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

    1 month after entry

  • In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale

    1 month after entry

  • +1 more secondary outcomes

Study Arms (3)

control group

NO INTERVENTION

The control group will be pre-tested with data collection tools and a post-test will be applied 1 month later. No intervention will be made.

video group

EXPERIMENTAL

A pre-test will be applied to the video group. Afterwards, a video containing the breastfeeding education prepared by the researcher will be watched. A post-test will be administered after the training. After 1 month, contact will be made and the test will be done again.

Other: Giving breastfeeding training

simulator group

EXPERIMENTAL

A pre-test will be applied to the simulator group. Afterwards, a training will be given by the researcher with a breastfeeding simulator. A final test will be given after the training. After 1 month, the contact will be made and the test will be done again.

Other: Giving breastfeeding training

Interventions

The control group will not be interfered with. Breastfeeding training will be given to the video and simulator group and the 3 groups will be compared.

simulator groupvideo group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be 18 years or older,
  • Mothers whose babies were admitted to the neonatal unit after delivery and stayed in the mother's guesthouse,
  • Mothers of infants who did not breastfeed and bond within the first 30-60 minutes after birth and were immediately admitted to the newborn,
  • Mothers who have not started breastfeeding their babies,
  • Literate,
  • Ability to understand and answer questions

You may not qualify if:

  • Mothers whose babies were admitted to the neonatal unit after 24 hours
  • Mothers who do not stay in the mother's guesthouse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Trial model with randomized control, pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2022

First Posted

February 21, 2023

Study Start

June 17, 2022

Primary Completion

April 1, 2023

Study Completion

June 15, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations