- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05059028
Effect of Oxytocin Massage and Music on Breastfeeding
Effect of Oxytocin Massage and Music on Breastfeeding: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Other
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Istanbul, Other, Turkey, 34862
- Istanbul University Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
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Active Comparator: Oxytocin massage
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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. |
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Diagnostic and Evaluation Scale
Time Frame: 1 month
|
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
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Breastfeeding Self-Efficacy Scale short form
Time Frame: 1 month
|
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.
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1 month
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Infant Nutrition Attitude Scale
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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