Breastfeeding Clinical Trial
Official title:
Effect of Oxytocin Massage and Music on Breastfeeding: Randomized Controlled Trial
NCT number | NCT05059028 |
Other study ID # | IstUC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2021 |
Est. completion date | July 30, 2022 |
Verified date | August 2022 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 30, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - mothers who are 20 years or older, - Primiparous delivery, - Single fetus pregnancy, - Born at term (38-42 weeks of gestation), - Your baby's Apgar score is at least 8 points in the 5th minute, - Being literate, - Interviewed on the first day after birth, - Does not have a problem that prevents breastfeeding, - No complications during and after birth, - Staying in the same room with her baby after birth, - There is no health problem that may affect the baby's suckling, - Those who become pregnant by normal means (without IVF, IVF, etc.), - Babies with a birth weight of more than 2500, - Mothers without chronic disease, - Non-smoking mothers, - Mothers who do not give formula to their babies Exclusion Criteria: - The mother/baby has a serious health problem that prevents breastfeeding, - Absence from education for at least two sessions, - Women with a known disease (HIV, hepatitis B, hepatitis C, etc.) known to be transmitted through breast milk will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University Cerrahpasa | Istanbul | Other |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breastfeeding Diagnostic and Evaluation Scale | LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. Each letter of the acronym LATCH denotes an area of assessment. "L" is for how well the infant latches onto the breast. "A" is for the amount of audible swallowing noted. "T" is for the mother's nipple type. "C" is for the mother's level of comfort. "H" is for the amount of help the mother needs to hold her infant to the breast. The minimum point is 0 and maximum point is 10. The highest 10 points to be obtained from the scale are taken, and a high score indicates good breastfeeding success. | 1 month | |
Primary | Breastfeeding Self-Efficacy Scale short form | The questionnaire is a 14-item self-administered instrument derived from the original 33-items, that measures breastfeeding confidence. All items are preceded on a 5-point Likert scale, ranging from 1 to 5. Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy. | 1 month | |
Primary | Infant Nutrition Attitude Scale | The scale is composed of 17 items with a 5-point Likert scale ranging from 1 to 5. The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding. Total IIFAS scores can be further categorized into groups: 1) positive to breastfeeding (IIFAS score 70-85), 2) neutral (IIFAS score 49-69), and 3) positive to formula feeding (IIFAS score 17-48). | 1 month |
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