NCT05923320

Brief Summary

Introduction:Breastfeeding and childhood vaccinations are the two most important public health practices for the healthy growth and development of the newborn. Aim:To investigate the effects of comprehensive training to be given to post-partum women who have just given birth in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital, obstetrics and gynecology service, on their attitudes towards childhood vaccinations and breastfeeding. Method:This research is in the type of repetitive measurement experimental design with pre-test post-test control group. The sample consisted of 30 experimental and 30 control groups selected from the universe by computer-assisted randomization method. The experimental group was hospitalized on the first day after birth, on the 2nd-7th day. days and 30-42. The trainings will be given to the post-partum women individually. About 30 minutes of training will be given and their questions, if any, will be answered. Then, data collection tools will be applied when the babies are 2,4,6 months old (posttest). Conclusion:This study will enable the comprehensive education to be given to post-partum women who have just given birth in the hospital, to improve their attitudes towards childhood vaccines and to increase the breastfeeding rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

June 7, 2023

Last Update Submit

July 24, 2024

Conditions

Keywords

Trainingbreast-feedingchildhood vaccinesnewbornpuerperant woman

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding Attitudes of The Evaluation Scale

    The highest score that can be obtained from the scale is 184, and as the score from the scale increases, women's attitudes towards breastfeeding are evaluated positively. Sentences with colored (yellow) colors will be scored as "I totally agree" 4-3-2-1-0 as positive attitude, other sentences will be considered negative and reverse scoring will be done as "I totally agree" 0-1-2-3-4. The scale total score is 184. The score of positive items is 88, and the score of negative items is 96. As the score increases, it is evaluated that the breastfeeding attitude is positive.

    Change from "Breastfeeding Attitudes of The Evaluation Scale" scores at 6 months

  • The Parent Attitudes About childhood vaccines scale (PACV)

    It consists of 15 questions. In the first two questions, the participant was asked whether the child was the firstborn and the degree of closeness with the child. The main PACV items start from the 3rd question and consist of a total of 15 items and 3 sub-areas (Question 3-Question 15). These sub-fields are; behavior are general attitudes and safety-efficacy domains. Evaluation scores of the scale; 2 points for hesitant answers, 0 points for unhesitating answers, 1 point for "I'm not sure or I don't know" answers. Items 1 and 2, in which the answer "I don't know" is considered as missing data, are excluded when scoring them, and 2 points are assigned to hesitant responses and 0 points to unhesitating responses for these items. After the scores of each item are given, they are added together;The total raw score is calculated.

    Change from "The Parent Attitudes About childhood vaccines scale " scores at 6 months

Study Arms (2)

experimental group -assigned intervention

EXPERIMENTAL

The experimental group was given training on infancy vaccines and breastfeeding. The times of the trainings are determined based on the Postpartum Care Management Guide of the Ministry of Health. In the hospital on the first day after birth, 2-7. days and 30-42. Three days in total, trainings were given on breastfeeding and childhood vaccinations by making home visits. The training content has been prepared by taking into account the Ministry of Health Breastfeeding Guide (5) and the Ministry of Health's vaccination calendar and the Primary Care Vaccine Guide. The trainings will be given to the puerperant women individually. About 30 minutes of training will be given and their questions, if any, will be answered.

Behavioral: training

control grouup

NO INTERVENTION

no training was given to the control group

Interventions

trainingBEHAVIORAL

The experimental group was given training on infancy vaccines and breastfeeding. The times of the trainings are determined based on the Postpartum Care Management Guide of the Ministry of Health. In the hospital on the first day after birth, 2-7. days and 30-42. Three days in total, trainings were given on breastfeeding and childhood vaccinations by making home visits. The training content has been prepared by taking into account the Ministry of Health Breastfeeding Guide (5) and the Ministry of Health's vaccination calendar and the Primary Care Vaccine Guide. The trainings will be given to the puerperant women individually. About 30 minutes of training will be given and their questions, if any, will be answered.

experimental group -assigned intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspuerprant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Literate
  • and over years old
  • Those who volunteered to participate in the study women who do not have communication and mental difficulties

You may not qualify if:

  • Those who do not fill out the entire questionnaire
  • Having a newborn's disease
  • Having a postpartum depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Faculty of Health Sciences

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingVaccination RefusalHypersensitivity

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorImmune System Diseases

Study Officials

  • duygu murat öztürk, PhD

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single paticipant
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A repetitive measure design with a pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 28, 2023

Study Start

March 14, 2022

Primary Completion

January 10, 2023

Study Completion

June 6, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared

Locations