Protocol summary

Study aim
The aim of this study is to evaluate the effect of breastfeeding education given using teach-back method on breastfeeding success and breastfeeding self-efficacy of mothers.
Design
Randomized, intervention and control group experimental study consisting of 88 puerperal women followed up between March and August.
Settings and conduct
The study was conducted as an blinded, randomized and controlled experimental study between March 2022 and November 2022. Computer-assisted randomization method was used to distribute the groups homogeneously.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Being over 18 years old • Delivering at term and healthy • Having a healthy newborn • Absence of a condition that prevents breastfeeding in the baby exclusion criteria: . Having a condition that prevents breastfeeding • Not knowing Turkish • Having a hearing and speech disability
Intervention groups
In the first 24 hours after birth, women were interviewed and personal information forms and scales were applied before the education. While training was given to the intervention group with the Teach-back Method, standard training was given to the control group by the service nurses. At the end of the training, the scales were reapplied. Interviews were made again in the first month after birth and the scales were repeated.
Main outcome variables
Breastfeeding success and breastfeeding self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220509054795N2
Registration date: 2022-11-10, 1401/08/19
Registration timing: retrospective

Last update: 2022-11-10, 1401/08/19
Update count: 0
Registration date
2022-11-10, 1401/08/19
Registrant information
Name
Eda CANGÖL
Name of organization / entity
Çanakkale Onsekiz Mart Üniversitesi
Country
Turkey
Phone
+90 286 218 13 97
Email address
edacangol@comu.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-08-07, 1401/05/16
Actual recruitment start date
2022-03-01, 1400/12/10
Actual recruitment end date
2022-08-07, 1401/05/16
Trial completion date
2022-08-07, 1401/05/16
Scientific title
The Effect of Breastfeeding Education Given by Teach-Back Method on Breastfeeding Self-Efficacy and Breastfeeding Success: A Randomized Controlled Experimental Study
Public title
The effect of education on breastfeeding self-efficacy and success
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Living in Çorlu district of Tekirdağ province Being 18 years or older Ability to read and write Giving a term and healthy birth Having a healthy newborn Absence of anomaly that will prevent breastfeeding in the baby
Exclusion criteria:
Having a condition that prevents breastfeeding (mastitis, drug use, psychological disorders, etc.) Not knowing Turkish Hearing or speech impairment
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 88
Randomization (investigator's opinion)
Randomized
Randomization description
88 puerperant women who gave birth in Tekirdağ Çorlu State Hospital Gynecology Service between March 2022 and November 2022 and fulfilling the research criteria were included in the study. The research was conducted as an open-label, blinded, randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously. For this purpose, 88 sets were created by using the functions on the internet address "https://www.random.org/integer-sets" and each of these sets included 8 participants, 4 participants from each study group. As the next process, 88 sets were shown with 1 number each, and 11 numbers between 1 and 88 were generated using the "RANDOMLY SEARCH" function in Excel, and 11 sets to be used in randomization were randomly determined. Thus, in order to reduce selection bias and control the variables that may affect the outcome parameters, 44 of the participants were randomly assigned to the experimental and 44 to the control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Çanakkale Onsekiz Mart University Graduate Education Institute Scientific Research Ethics Committee
Street address
Çanakkale 18 Mart University Terzioğlu Campus Graduate Education Institute
City
Çanakkale
Postal code
17000
Approval date
2021-12-10, 1400/09/19
Ethics committee reference number
2021-YÖNP-0841

Health conditions studied

1

Description of health condition studied
The effect of breastfeeding education given by teach-back method on breastfeeding self-efficacy and breastfeeding success
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-efficacy of the puerperant about breastfeeding
Timepoint
Pretest and posttest, after 1 month
Method of measurement
Postpartum breastfeeding self-efficacy scale (short form)

2

Description
Evaluation of breastfeeding education given by teaching method
Timepoint
During education
Method of measurement
Teach-Back monitoring tool

3

Description
Puerperant’ s success in breastfeeding
Timepoint
Pretest and posttest, after 1 month
Method of measurement
Breastfeeding Diagnostic Tool LATCH

Secondary outcomes

empty

Intervention groups

1

Description
The first interview with the women in the intervention group was made within the first 24 hours after delivery in their own room in the obstetrics ward. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. In accordance with the content of the Breastfeeding Training Guide, the women in the intervention group were provided with training and consultancy services on the subjects they needed about breastfeeding with the Teach-Back Method. While the intervention group was being trained, the researcher's application of the method was evaluated by a healthcare professional using the Teach-Back Observation Tool. After the training, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were re-applied to the women before the training. The scales were repeated in the 1st month postpartum so that the permanence of the information learned in the previous interview was evaluated.
Category
Behavior

2

Description
The first interview with the women in the control group was made in the women's room in the obstetrics ward within the first 24 hours after delivery. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. Women were given standard training and consultancy services on breastfeeding by gynecology and obstetrics nurses. At the end of the trainings, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were reapplied. The Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale, which were administered to the women before the training in the 1st month postpartum, were re-applied and the permanence of the information learned in the previous interview was evaluated.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tekirdag Corlu State Hospital
Full name of responsible person
Elif Ocaktan Çetindemir
Street address
Zafer Mahallesi, Bulent Ecevit Bulvari, No:33, 59850 Corlu/ Tekirdag
City
Tekirdağ
Postal code
59850
Phone
+90 282 693 33 00
Email
elf.ocktn.1996@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Çanakkale 18 Mart University
Full name of responsible person
Eda Cangöl
Street address
Çanakkale 18 Mart University Terzioğlu Campüs
City
Çanakkale
Postal code
17000
Phone
+90 546 215 89 74
Email
elf.ocktn.1996@gmail.com
Grant name
none
Grant code / Reference number
none
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Çanakkale 18 Mart University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Çanakkale 18 Mart University
Full name of responsible person
Elif Ocaktan Çetindemir
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale 18 Mart University Terzioğlu Campus Graduate Education Institute
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 05 25
Email
elf.ocktn.1996@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Çanakkale 18 Mart University
Full name of responsible person
Elif Ocaktan Çetindemir
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale 18 Mart University Terzioglu Campus Graduate Education Institute
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 05 25
Email
elf.ocktn.1996@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Çanakkale18 Mart Üniversity
Full name of responsible person
Elif Ocaktan Çetindemir
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale 18 Mart University Terzioğlu Campus Graduate Education Institute
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 05 25
Email
elf.ocktn.1996@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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