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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oxytocin massage AND music therapy
Oxytocin massage: It is a massage that will accelerate the work of the parasympathetic nerves in order to transmit the oxytocin production stimulus to the posterior lobe of the brain. Massage the scapula from the cervical 7th to the 5th-6th spine, spinal (vertebral), 1-2 cm around the spine, both thumbs up and then 2-3 times down, in a small circular clockwise, downward and upward movements. It is a form of massage by pressing hard. Music intervention: In order to decide on the type of music to be played to the mothers during breastfeeding, three samples (Pentatonic, Büzürk makam and classical music) selected by the researcher will be asked to the postpartum mother, and the music preferred by the mothers will be determined. It will be ensured that mothers listen to the music determined 5 minutes before the breastfeeding session for 7 days and continue breastfeeding while the same music is playing.

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul Other

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

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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