Breast FeedingNCT05923320
The Effect of Education Given to Postpartum Women on Their Attitudes Towards Childhood Vaccinations and Breastfeeding
A study testing training in people with Breast Feeding and Vaccination Refusal, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Vaccination Refusal, Training Group, Sensitivity
- What is being tested?
- training
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate
- 18 and over years old
- Those who volunteered to participate in the study women who do not have communication and mental difficulties
Who cannot join
- Those who do not fill out the entire questionnaire
- Having a newborn's disease
- Having a postpartum depression
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University Faculty of Health Sciences
Amasya
About this study
Official title: Effect of an Educational Intervention for Postpartum Mothers on Their Attitudes Towards Childhood Vaccinations and Breastfeeding:
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.
Read more
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.
Read the detailed description
Introduction:Breastfeeding and childhood vaccinations are the two most important public health practices for the healthy growth and development of the newborn. Although vaccination is one of the most effective and most successful health protection-improvement practices, the cases of vaccine refusal that emerged after 1990 in the world and after 2010 in our country, which increased rapidly, constitute a serious global problem in terms of vaccine-preventable epidemics. is doing. The number of anti-vaccination families has been increasing in recent years. The number of families who do not want to be vaccinated, which was around 1400 in 2014 in our country, is more than 23000 in 2017. If this increase continues like this, it is likely that social immunity will deteriorate and epidemics will occur in the following years. Despite all vaccination campaigns in the world, an average of 1.5 million people die every year from vaccine-preventable diseases.
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 research will consist of newly delivered post-partum women in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital gynecology and obstetrics service between 14 March 2022 and September 2023. The universe of the research will consist of all post-partum women who gave birth in the hospital where the research was conducted at the time of the research. 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. Trainings on breastfeeding and childhood vaccinations will be given three times in total by making home visits. The training content has been prepared by taking into account the Ministry of Health Breastfeeding Guide, the Ministry of Health's vaccination schedule, and the Primary Care Vaccination Guide. 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. It is thought that the results of the study will support the post-partum women, physically, socially and culturally and will guide the programs that will improve the newborns and post-partum women healths.
- Being tested
- training
- Keywords
- Training, breast-feeding, childhood vaccines, newborn, puerperant woman
- Medical subject headings
- Breast Feeding, Vaccination Refusal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: training |
| control grouup | No intervention | no training was given to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from "The Parent Attitudes About childhood vaccines scale " scores at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start14 Mar 2022
- Primary completion10 Jan 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A repetitive measure design with a pretest-posttest control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- duygu murat öztürk, PhD, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923320
- Sponsor's protocol ID
- AmasyaU18
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Intervention for Postpartum Mothers on Their Attitudes Towards Childhood Vaccinations and Breastfeeding:
- ClinicalTrials.gov ID
- NCT05923320
- Acronym / sponsor ID
- AmasyaU18
- Keywords
- Training, breast-feeding, childhood vaccines, newborn, puerperant woman
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:Breastfeeding and childhood vaccinations are the two most important public health practices for the healthy growth and development of the newborn. Although vaccination is one of the most effective and most successful health protection-improvement practices, the cases of vaccine refusal that emerged after 1990 in the world and after 2010 in our country, which increased rapidly, constitute a serious global problem in terms of vaccine-preventable epidemics. is doing. The number of anti-vaccination families has been increasing in recent years. The number of families who do not want to be vaccinated, which was around 1400 in 2014 in our country, is more than 23000 in 2017. If this increase continues like this, it is likely that social immunity will deteriorate and epidemics will occur in the following years. Despite all vaccination campaigns in the world, an average of 1.5 million people die every year from vaccine-preventable diseases.
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 research will consist of newly delivered post-partum women in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital gynecology and obstetrics service between 14 March 2022 and September 2023. The universe of the research will consist of all post-partum women who gave birth in the hospital where the research was conducted at the time of the research. 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. Trainings on breastfeeding and childhood vaccinations will be given three times in total by making home visits. The training content has been prepared by taking into account the Ministry of Health Breastfeeding Guide, the Ministry of Health's vaccination schedule, and the Primary Care Vaccination Guide. 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. It is thought that the results of the study will support the post-partum women, physically, socially and culturally and will guide the programs that will improve the newborns and post-partum women healths.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A repetitive measure design with a pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| experimental group -assigned intervention | Experimental | Behavioral: trainingThe 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. |
| control grouup | No intervention | –no training was given to the control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Literate
- 18 and over years old
- Those who volunteered to participate in the study women who do not have communication and mental difficulties
Key exclusion criteria (3 listed)
- Those who do not fill out the entire questionnaire
- Having a newborn's disease
- Having a postpartum depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trainingThe 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. | Behavioural | experimental group -assigned intervention |
Primary outcome
Breastfeeding Attitudes of The Evaluation Scale
Time frame: Change from "Breastfeeding Attitudes of The Evaluation Scale" scores at 6 months
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.
The Parent Attitudes About childhood vaccines scale (PACV)
Time frame: Change from "The Parent Attitudes About childhood vaccines scale " scores at 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No. individual participant data will not be shared
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
duygu murat öztürk, PhD principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Breast Feeding and Vaccination Refusal, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Attitudes of The Evaluation Scale (time frame: Change from "Breastfeeding Attitudes of The Evaluation Scale" scores at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.