Effect of Oxytocin Massage and Music on Breastfeeding
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedAugust 8, 2022
August 1, 2022
6 months
September 13, 2021
August 4, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
Oxytocin massage
ACTIVE COMPARATORmusic therapy
ACTIVE COMPARATORcontrol group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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,
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University Cerrahpasa
Istanbul, Other, 34862, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2021
First Posted
September 28, 2021
Study Start
November 1, 2021
Primary Completion
May 1, 2022
Study Completion
July 30, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share