Breast FeedingNCT05735821
The Effectiveness of the Training Given to the Unable to Breastfeed Mothers Staying in the Mother's Hotel
A study testing Giving breastfeeding training in people with Breast Feeding and Separation, Family, run by HATİCE TETİK METİN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Separation, Family
- What is being tested?
- Giving breastfeeding training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2022to 15 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Mothers whose babies were admitted to the neonatal unit after 24 hours
- Mothers who do not stay in the mother's guesthouse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep
Hatice Tetik METİN, +90 5413158485
About this study
Official title: Comparison of Video and Breastfeeding Simulator Supported Training Activities for Mothers Who Couldn't Breastfeed Their Baby Staying in the Mother's Hotel
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.
Read more
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.)
Read the detailed description
The universe of the research; Bitlis State Hospital Newborn Unit will be formed by mothers whose babies are hospitalized and who stay at the mother's hotel.
Sample of the research:
G.Power 3.1.9.4 package program was used to calculate the sample size foreseen for the research. In the calculation made in this direction; sample size, 95% confidence interval, 0.6 effect value for 80% power was used, and it was seen that at least 90 individuals should be included in the study in total. Since the study will be conducted in 2 intervention and 1 control groups, it has been observed that there should be 30 people in each group.
Content of the Training Provided for Developing Breastfeeding Behavior Change; Training materials and training contents will be created by the researcher based on the IMB Model and the training will be planned. Trainings will be video supported and simulator supported. The video will be prepared by the researcher. The video will be prepared in accordance with the techniques of 'educational video development for e-Learning'. Breastfeeding Simulator will be tried to be obtained by applying to the Tübitak project. If Tübitak project support cannot be obtained, the Breastfeeding Simulator will be provided by the researcher.
Data collection stages: Participants who meet the sample selection criteria will be informed about the scope of the research and their verbal and written consent will be obtained.
Data Collection Tools
- Socio-Demographic Data Questionnaire: The content will be created by the researcher by scanning the literature on the subject and in line with the suggestions of academicians specialized in Midwifery, Obstetrics and Gynecology Nursing.
- Breastfeeding Self-Efficacy Scale
- Maternal Attachment Scale
- Knowledge levels and attitudes of mothers towards breastfeeding:The content will be created by the researcher by scanning the literature on the subject and in line with the suggestions of academicians specialized in Midwifery, Obstetrics and Gynecology Nursing.
The research will consist of 2 stages;
- stage
The study will be started with the mothers in the control group. The mothers in the control group, who were selected in accordance with the sample selection criteria and agreed to be a participant, will be given data collection tools for the pre-test on the first day, and no intervention will be made other than the counseling given at the hospital. After 4 weeks from the pre-test, the mothers will be reached and the post-test will be applied.
Stage 2
The study will continue with the mothers in the Experimental group. Data collection tools will be applied to the mothers in the Experimental group, who were selected in accordance with the sample selection criteria and accepted to be a participant, for the pre-test on the first day to determine their levels. The training day will be planned for the mothers in the experimental group by determining the average length of stay of the babies. Training materials and training contents will be created by the researcher based on the IMB Model. The training period will be planned to last between 45 minutes and 1 hour. After the training, mothers will be given the opportunity to ask questions about the subjects they do not understand about the training given for 15 minutes and the training will be completed.
- Experimental Group; The mothers in the 1st group will be pre-tested with data collection tools before the training, then video-assisted training will be given and the post-test will be applied after the training. After the mothers in this group are completed, the second group will be started.
- Experimental Group; The mothers in the 2nd group will be pre-tested with the data collection tools before the training, then the Breastfeeding Simulator supported training will be given and the post-test will be applied after the training. Applications will be made to mothers participating in the training.
The retest of the two experimental groups will be applied 4 weeks after their training.
Statistical Analysis of Data
Analysis of the data will be done with SPSS 21.0 and will be studied at 95% confidence level. The kurtosis and skewness coefficients will be examined to determine the conformity of the variables to the normal distribution. It will be considered sufficient for the normal distribution that the kurtosis and skewness values obtained from the variables are between +3 and -3.
If normality is provided for the variables with skewness and kurtosis values between +3 and -3 obtained from the variables, parametric tests will be applied and non-parametric test techniques will be used for the variables outside this range. The independent groups t test for two groups, the examination of the variables providing normality in terms of variables with three or more groups, the ANOVA test, and the analysis of the variables that do not provide normality in terms of variables with three or more groups will be analyzed with the Kruskal test. In case of difference in ANOVA test, multiple comparisons will be analyzed with Tukey test and in Kruskal Wallis test with Mann Whitney test with bonferroni correction. Change will be analyzed by Iterative ANOVA test, in case of difference, multiple comparison dependent groups will be analyzed with t test. The relationship between categorical variables will be analyzed with the Chi-square test.
(NOTE: Consort Flow Chart will be followed)
- Conditions
- Breast Feeding, Separation, Family
- Being tested
- Giving breastfeeding training
- Keywords
- Mother Hotel, Breastfeeding Education, Video and Breastfeeding Simulator, IMB Model, Maternal Attachment
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving breastfeeding trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Giving breastfeeding training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.
Measured: 1 week after training and 1 month after retraining
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.
Measured: 1 month after entry
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.
Measured: 1 month after entry
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.
Measured: 1 month after entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 Jun 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial model with randomized control, pretest-posttest control group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HATİCE TETİK METİN
- Sponsor type
- University, hospital or other
- Collaborators
- Atlas University
- Responsible party
- Sponsor-investigator, HATİCE TETİK METİN, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735821
- Sponsor's protocol ID
- 2022/043
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video and Breastfeeding Simulator Supported Training Activities for Mothers Who Couldn't Breastfeed Their Baby Staying in the Mother's Hotel
- ClinicalTrials.gov ID
- NCT05735821
- Acronym / sponsor ID
- 2022/043
- Conditions
- Breast Feeding, Separation, Family
- Keywords
- Mother Hotel, Breastfeeding Education, Video and Breastfeeding Simulator, IMB Model, Maternal Attachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HATİCE TETİK METİNUniversity, hospital or other
- Collaborators
- Atlas University
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 21 Feb 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.
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.)
Detailed description
The universe of the research; Bitlis State Hospital Newborn Unit will be formed by mothers whose babies are hospitalized and who stay at the mother's hotel.
Sample of the research:
G.Power 3.1.9.4 package program was used to calculate the sample size foreseen for the research. In the calculation made in this direction; sample size, 95% confidence interval, 0.6 effect value for 80% power was used, and it was seen that at least 90 individuals should be included in the study in total. Since the study will be conducted in 2 intervention and 1 control groups, it has been observed that there should be 30 people in each group.
Content of the Training Provided for Developing Breastfeeding Behavior Change; Training materials and training contents will be created by the researcher based on the IMB Model and the training will be planned. Trainings will be video supported and simulator supported. The video will be prepared by the researcher. The video will be prepared in accordance with the techniques of 'educational video development for e-Learning'. Breastfeeding Simulator will be tried to be obtained by applying to the Tübitak project. If Tübitak project support cannot be obtained, the Breastfeeding Simulator will be provided by the researcher.
Data collection stages: Participants who meet the sample selection criteria will be informed about the scope of the research and their verbal and written consent will be obtained.
Data Collection Tools
- Socio-Demographic Data Questionnaire: The content will be created by the researcher by scanning the literature on the subject and in line with the suggestions of academicians specialized in Midwifery, Obstetrics and Gynecology Nursing.
- Breastfeeding Self-Efficacy Scale
- Maternal Attachment Scale
- Knowledge levels and attitudes of mothers towards breastfeeding:The content will be created by the researcher by scanning the literature on the subject and in line with the suggestions of academicians specialized in Midwifery, Obstetrics and Gynecology Nursing.
The research will consist of 2 stages;
- stage
The study will be started with the mothers in the control group. The mothers in the control group, who were selected in accordance with the sample selection criteria and agreed to be a participant, will be given data collection tools for the pre-test on the first day, and no intervention will be made other than the counseling given at the hospital. After 4 weeks from the pre-test, the mothers will be reached and the post-test will be applied.
Stage 2
The study will continue with the mothers in the Experimental group. Data collection tools will be applied to the mothers in the Experimental group, who were selected in accordance with the sample selection criteria and accepted to be a participant, for the pre-test on the first day to determine their levels. The training day will be planned for the mothers in the experimental group by determining the average length of stay of the babies. Training materials and training contents will be created by the researcher based on the IMB Model. The training period will be planned to last between 45 minutes and 1 hour. After the training, mothers will be given the opportunity to ask questions about the subjects they do not understand about the training given for 15 minutes and the training will be completed.
- Experimental Group; The mothers in the 1st group will be pre-tested with data collection tools before the training, then video-assisted training will be given and the post-test will be applied after the training. After the mothers in this group are completed, the second group will be started.
- Experimental Group; The mothers in the 2nd group will be pre-tested with the data collection tools before the training, then the Breastfeeding Simulator supported training will be given and the post-test will be applied after the training. Applications will be made to mothers participating in the training.
The retest of the two experimental groups will be applied 4 weeks after their training.
Statistical Analysis of Data
Analysis of the data will be done with SPSS 21.0 and will be studied at 95% confidence level. The kurtosis and skewness coefficients will be examined to determine the conformity of the variables to the normal distribution. It will be considered sufficient for the normal distribution that the kurtosis and skewness values obtained from the variables are between +3 and -3.
If normality is provided for the variables with skewness and kurtosis values between +3 and -3 obtained from the variables, parametric tests will be applied and non-parametric test techniques will be used for the variables outside this range. The independent groups t test for two groups, the examination of the variables providing normality in terms of variables with three or more groups, the ANOVA test, and the analysis of the variables that do not provide normality in terms of variables with three or more groups will be analyzed with the Kruskal test. In case of difference in ANOVA test, multiple comparisons will be analyzed with Tukey test and in Kruskal Wallis test with Mann Whitney test with bonferroni correction. Change will be analyzed by Iterative ANOVA test, in case of difference, multiple comparison dependent groups will be analyzed with t test. The relationship between categorical variables will be analyzed with the Chi-square test.
(NOTE: Consort Flow Chart will be followed)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Trial model with randomized control, pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Giving breastfeeding trainingA 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. |
| simulator group | Experimental | Other: Giving breastfeeding trainingA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Mothers whose babies were admitted to the neonatal unit after 24 hours
- Mothers who do not stay in the mother's guesthouse
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 |
|---|---|---|
| Giving breastfeeding trainingThe 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. | Other | simulator group, video group |
Primary outcome
In education groups; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire
Time frame: at admission
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.
In education groups; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form
Time frame: at admission
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.
In education groups; Measuring the bond between mother and baby with the Maternal Attachment Scale
Time frame: at admission
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.
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
Time frame: at admission
The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.
In the control group; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire
Time frame: at admission
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.
In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form
Time frame: at admission
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.
In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale
Time frame: at admission
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.
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
Time frame: at admission,
The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.
6 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 1 week after training and 1 month after retraining
In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form
Time frame: 1 month after entry
In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale
Time frame: 1 month after entry
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
Time frame: 1 month after entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giving breastfeeding training in people with Breast Feeding and Separation, Family, run by HATİCE TETİK METİN 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hatice Tetik Metin (+90 5413158485, hatice_meleyim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In education groups; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire (time frame: at admission). The study lists 8 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 23 Feb 2023.