BreastfeedingNCT05992753
Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
An observational study of Breastfeeding and Breast Milk Expression, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Background: Expressing breast milk in cases where breastfeeding is interrupted is important for infants to be fed breast milk however, many factors can affect mothers' breastfeeding experience, such as feeding attitudes and the level of social support. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breast Milk Expression, Feeding Behavior
- What is being tested?
- Questionnaire application
- How many people
- 455 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 5 Jan 2023
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research population consisted of women who were admitted to the postpartum and lactation units of a city hospital in Istanbul affiliated with the Turkish Ministry of Health. A power analysis was performed to determine the number of people to be included in the study.
Who may be able to join
- Volunteer to participate in the research
- 18 years of age or older
- In the 0-6 month postpartum period
- Must have a living baby
- Must continue breastfeeding
- Must express breast milk at least once after birth
Who cannot join
- Feeding the infant formula only
- Having hearing and/or speech impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels in the Early Postpartum Period: A Cross-sectional Study in Turkish Population
Background: Expressing breast milk in cases where breastfeeding is interrupted is important for infants to be fed breast milk however, many factors can affect mothers' breastfeeding experience, such as feeding attitudes and the level of social support. The aim of this study is to determine the relationship mothers' breast milk expression experience between infant feeding attitudes and perceived social support level.
Methods: This cross-sectional study was carried out in the postpartum and lactation unit of a city hospital in Istanbul, between September-November 2022. The study included 455 women who were volunteering to participate in the research, 18 years of age or older, in the 0-6 months postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk at least once after birth. Data were collected with Mother-Baby Introductory Information Form, Breast Milk Expression Experience Measure (BMEE), Iowa Infant Feeding Attitude Scale (IIFAS), and Multidimensional Scale of Perceived Social Support (MSPSS). The data were analyzed using the SPSS-21 statistical software package.
Read more
The main questions it aims to answer are:
- Which characteristics affect mothers' breast milk expression experiences, infant feeding attitudes, and perceived social support levels in the early postpartum period?
- Is there a relationship between mothers' experiences of breast milk expression and their infant feeding attitudes and social support levels in the early postpartum period?
- Being tested
- Questionnaire application
- Medical subject headings
- Breast Feeding, Breast Milk Expression, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire applicationOther
The research data were collected from 455 mothers admitted to the postpartum and lactation unit of a city hospital in Istanbul between September and November 2022. The mothers to be included in the study sample were determined according to the non-probability sampling method, considering the inclusion criteria of the study. The research data were collected by the researchers face-to-face through a questionnaire that lasted about 10-20 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-Baby Introductory Information Form
The form prepared by the researchers consists of 25 questions containing information about the mother, the infant, and the nutrition characteristics.
Measured: September 1st - November 30th 2022
Breast Milk Expression Experience Measure (BMEE)
The BMEE, which was developed to determine the breast milk expression experience of mothers, consists of 11 items. The BMEE is a five-point Likert type, ranging from one (strongly disagree) to five (strongly agree). It has three sub-dimensions: social support, learning experience, and personal experience. When the mean of the total items' score is less than three, the breast milk expression experience of the mothers is evaluated as negative.
Measured: September 1st - November 30th 2022
Iowa Infant Feeding Attitude Scale (IIFAS)
The scale was designed to evaluate women's attitudes towards breastfeeding and predict the duration of breastfeeding as well as the choice of infant feeding method. IIFAS consists of 17 items and is a five-point Likert type (one-strongly disagree to five-strongly agree). While nine items of the IIFAS contain positive attitudes about breastfeeding, the other eight items contain positive attitudes about formula feeding. The total IIFAS score can range from 17 to 85, with higher scores reflecting a positive attitude towards breastfeeding. Total IIFAS scores can be categorized into three groups: positive to breastfeeding (IIFAS score 70-85), neutral (IIFAS score 49-69), and positive to formula feeding (IIFAS score 17-48).
Measured: September 1st - November 30th 2022
Multidimensional Scale of Perceived Social Support (MSPSS)
MSPSS subjectively assesses the adequacy of social support from three different sources (family, friends, and a significant other), consists of 12 items, and is a seven-point Likert type (one-very strongly disagree to seven-very strongly agree). The lowest score to be obtained from MSPSS is 12, and the highest score is 84. The higher the total score, the higher the perceived social support.
Measured: September 1st - November 30th 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Sep 2022
- Primary completion30 Nov 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Arel University, Istanbul University - Cerrahpasa, Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992753
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels in the Early Postpartum Period: A Cross-sectional Study in Turkish Population
- ClinicalTrials.gov ID
- NCT05992753
- Acronym / sponsor ID
- 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Istanbul Arel University, Istanbul University - Cerrahpasa, Başakşehir Çam & Sakura City Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 15 Aug 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.
Background: Expressing breast milk in cases where breastfeeding is interrupted is important for infants to be fed breast milk however, many factors can affect mothers' breastfeeding experience, such as feeding attitudes and the level of social support. The aim of this study is to determine the relationship mothers' breast milk expression experience between infant feeding attitudes and perceived social support level.
Methods: This cross-sectional study was carried out in the postpartum and lactation unit of a city hospital in Istanbul, between September-November 2022. The study included 455 women who were volunteering to participate in the research, 18 years of age or older, in the 0-6 months postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk at least once after birth. Data were collected with Mother-Baby Introductory Information Form, Breast Milk Expression Experience Measure (BMEE), Iowa Infant Feeding Attitude Scale (IIFAS), and Multidimensional Scale of Perceived Social Support (MSPSS). The data were analyzed using the SPSS-21 statistical software package.
The main questions it aims to answer are:
- Which characteristics affect mothers' breast milk expression experiences, infant feeding attitudes, and perceived social support levels in the early postpartum period?
- Is there a relationship between mothers' experiences of breast milk expression and their infant feeding attitudes and social support levels in the early postpartum period?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research population consisted of women who were admitted to the postpartum and lactation units of a city hospital in Istanbul affiliated with the Turkish Ministry of Health. A power analysis was performed to determine the number of people to be included in the study.
Key inclusion criteria (6 listed)
- Volunteer to participate in the research
- 18 years of age or older
- In the 0-6 month postpartum period
- Must have a living baby
- Must continue breastfeeding
Key exclusion criteria (2 listed)
- Feeding the infant formula only
- Having hearing and/or speech impairments
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 |
|---|---|---|
| Questionnaire applicationThe research data were collected from 455 mothers admitted to the postpartum and lactation unit of a city hospital in Istanbul between September and November 2022. The mothers to be included in the study sample were determined according to the non-probability sampling method, considering the inclusion criteria of the study. The research data were collected by the researchers face-to-face through a questionnaire that lasted about 10-20 minutes. | Other | – |
Primary outcome
Mother-Baby Introductory Information Form
Time frame: September 1st - November 30th 2022
The form prepared by the researchers consists of 25 questions containing information about the mother, the infant, and the nutrition characteristics.
Breast Milk Expression Experience Measure (BMEE)
Time frame: September 1st - November 30th 2022
The BMEE, which was developed to determine the breast milk expression experience of mothers, consists of 11 items. The BMEE is a five-point Likert type, ranging from one (strongly disagree) to five (strongly agree). It has three sub-dimensions: social support, learning experience, and personal experience. When the mean of the total items' score is less than three, the breast milk expression experience of the mothers is evaluated as negative.
Iowa Infant Feeding Attitude Scale (IIFAS)
Time frame: September 1st - November 30th 2022
The scale was designed to evaluate women's attitudes towards breastfeeding and predict the duration of breastfeeding as well as the choice of infant feeding method. IIFAS consists of 17 items and is a five-point Likert type (one-strongly disagree to five-strongly agree). While nine items of the IIFAS contain positive attitudes about breastfeeding, the other eight items contain positive attitudes about formula feeding. The total IIFAS score can range from 17 to 85, with higher scores reflecting a positive attitude towards breastfeeding. Total IIFAS scores can be categorized into three groups: positive to breastfeeding (IIFAS score 70-85), neutral (IIFAS score 49-69), and positive to formula feeding (IIFAS score 17-48).
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: September 1st - November 30th 2022
MSPSS subjectively assesses the adequacy of social support from three different sources (family, friends, and a significant other), consists of 12 items, and is a seven-point Likert type (one-very strongly disagree to seven-very strongly agree). The lowest score to be obtained from MSPSS is 12, and the highest score is 84. The higher the total score, the higher the perceived social support.
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 15 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Breast Milk Expression, run by Halic 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 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: finished, as of the sponsor's last update on 15 Aug 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?
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?
Mother-Baby Introductory Information Form (time frame: September 1st - November 30th 2022). The study lists 4 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 15 Aug 2023.