Clinical trial NCT05594836: The Effect of Infant Calming Education on Maternal Role Perception, Maternal Attachment and Breastfeeding Self-Efficacy
Official title: The Effect of Infant Calming Training Given to Primiparous Mothers on Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Maternal criteria;

* Being primiparous
* Being over 18 years old
* Being literate
* Absence of multiple pregnancy
* Volunteering to participate in the research
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maternal Attachment Scale
timeFrame: 9 MONTHS
measure: Postpartum Breastfeeding Self-Efficacy Scale-Short Form
timeFrame: 9 MONTHS
measure: Semantic Difference Scale-Me as Mother
timeFrame: 9 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Nursing of Faculty
state: Center
Study officials:
affiliation: Ataturk University
name: ARZU SARIALİOĞLU, PHD
role: STUDY_DIRECTOR
References: