Infant DevelopmentNCT05594836
The Effect of Infant Calming Education on Maternal Role Perception, Maternal Attachment and Breastfeeding Self-Efficacy
A study testing Infant Calming Training in people with Infant Development, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The research is a randomized controlled experimental study. The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023. 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
- Infant Development
- What is being tested?
- Infant Calming Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2022to 6 Mar 2024
- 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
- Maternal criteria;
- Being primiparous
- Being over 18 years old
- Being literate
- Absence of multiple pregnancy
- Volunteering to participate in the research
Show all 11Show fewer
- Being open to communication and interaction
- Owning a smartphone (for education group - white noise) Criteria for the baby;
- Being older than 37 weeks of gestation
- Normal birth weight (between 2500-4000 g)
- Absence of a medical condition that would prevent sucking
Who cannot join
- Admission of the baby to the intensive care unit
- The presence of a chronic disease in the mother that will prevent baby care
- Having any diagnosed disease of the baby during the study
- Artificial feeding of the baby
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Infant Calming Training Given to Primiparous Mothers on Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy
The research is a randomized controlled experimental study. The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023.
The population of the study will be composed of primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdoğan University Training and Research Hospital between 01/12/2022 and 01/10/2023. All mothers who were hospitalized in the gynecology service during the data collection period and met the inclusion criteria will be included in the study and sample selection will not be made.
"Mother and Baby Descriptive Information Form", "Maternal Attachment Scale", "Postpartum Breastfeeding Self-Efficacy Scale-Short Form", "Semantic Difference Scale-Me as Mother" and "Sleep and Crying Diary" will be used to collect research data. Developing the 5S application, which is a baby calming technique, as an educational material in the research. A training booklet will be prepared and used by making use of the training materials that Harvey Karp shared with the researchers.
Read the detailed description
Type of Research The research is a randomized controlled experimental study. Place and Time of the Research The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023.
Population and Sample of the Research The population of the study will be composed of primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdoğan University Training and Research Hospital between 01/12/2022 and 01/10/2023. All mothers who were hospitalized in the gynecology service during the data collection period and met the inclusion criteria will be included in the study and sample selection will not be made.
Data Collection Tools "Mother and Baby Descriptive Information Form", "Maternal Attachment Scale", "Postpartum Breastfeeding Self-Efficacy Scale-Short Form", "Semantic Difference Scale-Me as Mother" and "Sleep and Crying Diary" will be used to collect research data. Developing the 5S application, which is a baby calming technique, as an educational material in the research. A training booklet will be prepared and used by making use of the training materials that Harvey Karp shared with the researchers.
Data Collection The mothers in the control and education groups who meet the inclusion criteria of the study will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for mothers who agree to participate in the study. Data collection will not be carried out simultaneously with the mothers in the training and control groups, in case the mothers in the ward may be affected by the training provided. According to a computer-generated randomization list, patients will be assigned to one of two groups using the closed-envelope technique.
Control Group: Mothers in the control group will not be given any treatment other than the standard neonatal care routinely given in the clinic. Mother and Baby Descriptive Information Form, Semantic Difference Scale (Me as a Mother) and Breastfeeding Self-Efficacy Scale will be filled in by face-to-face interview method, and the Baby Sleep Descriptive Information Form will be filled in during a period of time when the baby is sleeping and the mother is feeling well. and how to fill out the Crying Diary. Since it was deemed appropriate to collect the maternal attachment scale in the first and fourth months after birth, the data of the Maternal Attachment Scale will be collected via the online questionnaire sent to the mothers at the 4th week after birth. At the end of the 8th week, the data will be filled again with the Semantic Difference Scale (Me as the Mother), Maternal Attachment and Breastfeeding Self-Efficacy Scale from the mothers. Baby Sleep and Crying Diary forms will be received.
Training Group: Primiparous mothers followed in the gynecology service in the postpartum period will be given face-to-face Infant Calming Training, which lasts for approximately 30 minutes, during a time when the baby is sleeping and the mother is feeling well. After the training, the Mother and Baby Introductory Information Form, the Semantic Difference Scale (Me as the Mother) and the Breastfeeding Self-Efficacy Scale will be filled in by face-to-face interview method and information will be given on how to fill the Baby Sleep and Crying Diary. The mother will be given a blanket to swaddle her baby along with the prepared educational material, and the Sleeping Companion with a White Noise Sensor will be given to the mother. The data of the Maternal Attachment Scale will be collected through the online questionnaire sent to the mothers in the 4th week after birth. Meaning from mothers at the end of the 8th week. Data will be replenished with the Salary Difference Scale (Me as a Mother), Maternal Attachment and Breastfeeding Self-Efficacy Scale. Baby Sleep and Crying Diary forms will be received.
Evaluation of Data Evaluation of statistics will be done by blinding method. The analysis of the data will be done by the statistician. After ensuring that the data is coded and labeled in a way that preserves the blinding, the data will be submitted and data analysis will be performed.
The data will be analyzed with the SPSS for Windows 22 package program. The normality distribution of the data will be determined by the Kurtosis and Skewness coefficients. In the analysis of the data, numbers, percentages, mean and standard deviations, as well as the t-test for normally distributed measurements in the comparison of paired groups, for independent groups, and Mann Whitney U analysis for non-normally distributed measurements will be used. In the comparison of multiple groups, analysis of variance will be used for normally distributed measurements. Statistical significance will be accepted as p<0.05.
Ethical Principles of Research In order to carry out the research, official permission will be obtained from the relevant institution with ethical approval from the Ethics Committee of Atatürk University Faculty of Medicine. The purpose of the study will be explained to the mothers who meet the research group criteria, their questions will be answered and their verbal and written consents will be obtained. The mothers will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed.
- Conditions
- Infant Development
- Being tested
- Infant Calming Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Calming TrainingBehavioural
Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy during Infant Calming Training
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy Receives: Behavioral: Infant Calming Training |
| control | No intervention | not Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment Scale
The highest level of attachment occurs when the mother understands the baby's signs and symptoms and meets the baby's physical and emotional needs. A mother's loving attachment to her baby, that is, maternal attachment, is one of the most important elements that promotes the healthy growth and development of the child.
MBI was developed in 1994. MDS is a 4-point Likert-type scale that includes 26 items and is answered between always (4 points) and never (1 point). An overall score is obtained from the sum of all items. The lowest score that can be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment. The validity and reliability of the scale for Turkish society was carried out in 2009 and it was determined that it would be suitable for mothers who have babies between one and four months after birth.
Measured: 9 MONTHS
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
It was developed in 1999 to evaluate mothers' breastfeeding self-efficacy levels. The first version of the scale consists of 33 items. Later, in 2003, a 14-item short form of the scale was developed. It is easier to apply and evaluates self-efficacy correctly. The Breastfeeding Self-Efficacy Short Form is a five-point Likert-type scale (1= "I am not sure at all" and 5 = "I am always sure"). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was carried out in 2010.
Measured: 9 MONTHS
Semantic Difference Scale-Me as Mother
This scale measures the evaluation dimensions of the concept of "myself as a mother". The scale consists of 11 semantic pairs of opposite adjectives with 11 items and 7 points. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to prevent the participant from being biased while responding. The third, seventh, and eighth items were evaluated over "one" point instead of "seven" point. High total scores indicate positive maternal self-assessment. The scale was adapted to Turkish society in 2003.
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start19 Oct 2022
- Primary completion27 Dec 2023
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594836
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/692
- Status last verified
- Mar 2024
- First submitted
- 20 Oct 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Publications
Altay G, Sarialioglu A. The Effects of Baby Calming Training Provided to Primiparous Mothers on Maternal Role Perception, Maternal Attachment, and Breastfeeding Self-Efficacy: A Randomized Controlled Trial. Breastfeed Med. 2024 Dec;19(12):947-956. doi: 10.1089/bfm.2024.0247. Epub 2024 Oct 17.
PubMed 39417265
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Calming Training Given to Primiparous Mothers on Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy
- ClinicalTrials.gov ID
- NCT05594836
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/692
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 26 Oct 2022 (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 research is a randomized controlled experimental study. The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023.
The population of the study will be composed of primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdoğan University Training and Research Hospital between 01/12/2022 and 01/10/2023. All mothers who were hospitalized in the gynecology service during the data collection period and met the inclusion criteria will be included in the study and sample selection will not be made.
"Mother and Baby Descriptive Information Form", "Maternal Attachment Scale", "Postpartum Breastfeeding Self-Efficacy Scale-Short Form", "Semantic Difference Scale-Me as Mother" and "Sleep and Crying Diary" will be used to collect research data. Developing the 5S application, which is a baby calming technique, as an educational material in the research. A training booklet will be prepared and used by making use of the training materials that Harvey Karp shared with the researchers.
Detailed description
Type of Research The research is a randomized controlled experimental study. Place and Time of the Research The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023.
Population and Sample of the Research The population of the study will be composed of primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdoğan University Training and Research Hospital between 01/12/2022 and 01/10/2023. All mothers who were hospitalized in the gynecology service during the data collection period and met the inclusion criteria will be included in the study and sample selection will not be made.
Data Collection Tools "Mother and Baby Descriptive Information Form", "Maternal Attachment Scale", "Postpartum Breastfeeding Self-Efficacy Scale-Short Form", "Semantic Difference Scale-Me as Mother" and "Sleep and Crying Diary" will be used to collect research data. Developing the 5S application, which is a baby calming technique, as an educational material in the research. A training booklet will be prepared and used by making use of the training materials that Harvey Karp shared with the researchers.
Data Collection The mothers in the control and education groups who meet the inclusion criteria of the study will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for mothers who agree to participate in the study. Data collection will not be carried out simultaneously with the mothers in the training and control groups, in case the mothers in the ward may be affected by the training provided. According to a computer-generated randomization list, patients will be assigned to one of two groups using the closed-envelope technique.
Control Group: Mothers in the control group will not be given any treatment other than the standard neonatal care routinely given in the clinic. Mother and Baby Descriptive Information Form, Semantic Difference Scale (Me as a Mother) and Breastfeeding Self-Efficacy Scale will be filled in by face-to-face interview method, and the Baby Sleep Descriptive Information Form will be filled in during a period of time when the baby is sleeping and the mother is feeling well. and how to fill out the Crying Diary. Since it was deemed appropriate to collect the maternal attachment scale in the first and fourth months after birth, the data of the Maternal Attachment Scale will be collected via the online questionnaire sent to the mothers at the 4th week after birth. At the end of the 8th week, the data will be filled again with the Semantic Difference Scale (Me as the Mother), Maternal Attachment and Breastfeeding Self-Efficacy Scale from the mothers. Baby Sleep and Crying Diary forms will be received.
Training Group: Primiparous mothers followed in the gynecology service in the postpartum period will be given face-to-face Infant Calming Training, which lasts for approximately 30 minutes, during a time when the baby is sleeping and the mother is feeling well. After the training, the Mother and Baby Introductory Information Form, the Semantic Difference Scale (Me as the Mother) and the Breastfeeding Self-Efficacy Scale will be filled in by face-to-face interview method and information will be given on how to fill the Baby Sleep and Crying Diary. The mother will be given a blanket to swaddle her baby along with the prepared educational material, and the Sleeping Companion with a White Noise Sensor will be given to the mother. The data of the Maternal Attachment Scale will be collected through the online questionnaire sent to the mothers in the 4th week after birth. Meaning from mothers at the end of the 8th week. Data will be replenished with the Salary Difference Scale (Me as a Mother), Maternal Attachment and Breastfeeding Self-Efficacy Scale. Baby Sleep and Crying Diary forms will be received.
Evaluation of Data Evaluation of statistics will be done by blinding method. The analysis of the data will be done by the statistician. After ensuring that the data is coded and labeled in a way that preserves the blinding, the data will be submitted and data analysis will be performed.
The data will be analyzed with the SPSS for Windows 22 package program. The normality distribution of the data will be determined by the Kurtosis and Skewness coefficients. In the analysis of the data, numbers, percentages, mean and standard deviations, as well as the t-test for normally distributed measurements in the comparison of paired groups, for independent groups, and Mann Whitney U analysis for non-normally distributed measurements will be used. In the comparison of multiple groups, analysis of variance will be used for normally distributed measurements. Statistical significance will be accepted as p<0.05.
Ethical Principles of Research In order to carry out the research, official permission will be obtained from the relevant institution with ethical approval from the Ethics Committee of Atatürk University Faculty of Medicine. The purpose of the study will be explained to the mothers who meet the research group criteria, their questions will be answered and their verbal and written consents will be obtained. The mothers will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Infant Calming TrainingPerception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy |
| control | No intervention | –not Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Maternal criteria;
- Being primiparous
- Being over 18 years old
- Being literate
- Absence of multiple pregnancy
Key exclusion criteria (4 listed)
- Admission of the baby to the intensive care unit
- The presence of a chronic disease in the mother that will prevent baby care
- Having any diagnosed disease of the baby during the study
- Artificial feeding of the baby
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 |
|---|---|---|
| Infant Calming TrainingPerception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy during Infant Calming Training | Behavioural | Training |
Primary outcome
Maternal Attachment Scale
Time frame: 9 MONTHS
The highest level of attachment occurs when the mother understands the baby's signs and symptoms and meets the baby's physical and emotional needs. A mother's loving attachment to her baby, that is, maternal attachment, is one of the most important elements that promotes the healthy growth and development of the child. MBI was developed in 1994. MDS is a 4-point Likert-type scale that includes 26 items and is answered between always (4 points) and never (1 point). An overall score is obtained from the sum of all items. The lowest score that can be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment. The validity and reliability of the scale for Turkish society was carried out in 2009 and it was determined that it would be suitable for mothers who have babies between one and four months after birth.
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
Time frame: 9 MONTHS
It was developed in 1999 to evaluate mothers' breastfeeding self-efficacy levels. The first version of the scale consists of 33 items. Later, in 2003, a 14-item short form of the scale was developed. It is easier to apply and evaluates self-efficacy correctly. The Breastfeeding Self-Efficacy Short Form is a five-point Likert-type scale (1= "I am not sure at all" and 5 = "I am always sure"). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was carried out in 2010.
Semantic Difference Scale-Me as Mother
Time frame: 9 MONTHS
This scale measures the evaluation dimensions of the concept of "myself as a mother". The scale consists of 11 semantic pairs of opposite adjectives with 11 items and 7 points. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to prevent the participant from being biased while responding. The third, seventh, and eighth items were evaluated over "one" point instead of "seven" point. High total scores indicate positive maternal self-assessment. The scale was adapted to Turkish society in 2003.
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 8 Mar 2024.
- Derived from this study: PubMed 39417265Altay G, Sarialioglu A. The Effects of Baby Calming Training Provided to Primiparous Mothers on Maternal Role Perception, Maternal Attachment, and Breastfeeding Self-Efficacy: A Randomized Controlled Trial. Breastfeed Med. 2024 Dec;19(12):947-956. doi: 10.1089/bfm.2024.0247. Epub 2024 Oct 17.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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.
ARZU SARIALİOĞLU, PHD study director
Ataturk 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 Infant Calming Training in people with Infant Development, run by Ataturk 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 11 inclusion and 4 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 8 Mar 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?
Maternal Attachment Scale (time frame: 9 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594836, which also lists 1 linked publication.
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 8 Mar 2024.