- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06536608
The Effect of Oketani Breast Massage on Breastfeeding
The Effect of Oketani Breast Massage on Breastfeeding Success, Breastfeeding Self-Efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Filiz Ünal Toprak, PhD
- Phone Number: 05077732090
- Email: filizore1@gmail.com
Study Locations
-
-
-
Çankırı, Turkey
- Recruiting
- Cankiri State Hospital
-
Contact:
- Sakine Yılmaz, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To volunteer to participate in the study,
- To be over 18 years of age,
- To be able to read and write,
- To be able to read and understand Turkish,
- To have no hearing, speech or visual impairments,
- To have received breastfeeding training at a pregnancy school,
- To be healthy in the 36th week of primiparous pregnancy.
Exclusion Criteria:
- Obstacles to communication include having a visual, hearing or perception disorder,
- Not being able to read or write,
- Having a psychiatric illness,
- Being multiparous and having a vaginal birth,
- Having a risky pregnancy.
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 |
|---|---|
|
Experimental: Massage Group
Pregnant women who meet the inclusion criteria assigned to the Oketani Massage group will be informed about the study and their written and verbal consent will be obtained.
Pregnant women will be asked to fill out the 'Introductory Characteristics Information Form' and 'Prenatal Breastfeeding Self-Efficacy Scale Short Form' at the first meeting before the training and then they will be given breastfeeding training and massage prepared with the Oketani method. 2 weeks after the training, the researcher will apply Oketani breast massage twice before the mother enters the operating room and once before the mother's first breastfeeding in the operating room or in the ward.
One day after birth, they will be asked to answer the Postpartum Breastfeeding Self-Efficacy Scale Short Form, LACTH and Visual Comparison Scale Satisfaction (VAS-S) scale.
|
The Oketani Method is based upon practical breastfeeding theory, but is original in its practice. Oketani breast massage improves breastmilk secretion, can prevent and treat problems such as mastitis. In addition, the massage is painless, allowing your body to relax and breathe, something very much appreciated by mothers. The Oketani breast massage consists of massaging and milking the base of the breasts. These delicate glands are massaged as well as protected.
Other Names:
|
|
No Intervention: Control Group
Pregnant women who meet the inclusion criteria and who are assigned to the control group will be informed about the study and their written and verbal consent will be obtained.
Pregnant women will be asked to fill out the 'Introductory Characteristics Information Form' and 'Prenatal Breastfeeding Self-Efficacy Scale Short Form' at the first meeting.
One day after birth, they will be asked to answer the Postpartum Breastfeeding Self-Efficacy Scale Short Form and LACTH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form
Time Frame: 1. week, 2. week and after labor 1. day
|
The first form of the scale developed by Dennis and Faux was designed as 33 items, but after a second study, Dennis revised the scale and created a 14-item short form. The Turkish validity and reliability study of the scale was conducted by Aluş Tokat et al. in 2017. The scale can be administered in prenatal and postnatal periods and measures how competent women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure (1), not very sure (2), sometimes sure (3), sure (4), very sure (5). The lowest score that can be obtained from all the evaluation scores of the scale is 14 and the highest score is 70. A low total score on the scale indicates a low perception of breastfeeding self-efficacy. In the original scale, the Cronbach's alpha reliability coefficient of the prenatal form was 0.87 and the Cronbach's alpha reliability coefficient of the postnatal form was 0.86. |
1. week, 2. week and after labor 1. day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Assessment Scale - Satisfaction (VAS - S)
Time Frame: After labor 1. day
|
The VAS is also used to measure other components besides pain, such as satisfaction.In our study, the VAS will also be used to assess mothers' breastfeeding satisfaction levels.
The Visual Assessment Scale - Satisfaction (VAS-S) is a 10 cm ruler with the expression "Not satisfied" on one end and "Very satisfied" on the other end.
The mother is asked to rate her satisfaction with breastfeeding after the training from 1 to 10. High scores on the scale indicate that the satisfaction of the recipients is also high
|
After labor 1. day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Filiz Ünal Toprak, PhD, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FÜT-02
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.
Clinical Trials on Breast Feeding
-
London School of Hygiene and Tropical MedicineFHI 360; AFRICSante; Centre MurazCompleted
-
The Hong Kong Polytechnic UniversityCompletedParents | Breast Feeding, ExclusiveHong Kong
-
Loma Linda UniversityNot yet recruitingPregnancy Related | Breast Feeding, ExclusiveUnited States
-
University of FloridaCompleted
-
Emel GÜÇLÜ CİHANKahramanmaras Sutcu Imam UniversityRecruitingBreast Feeding | Primiparity | Exclusive Breast Feeding | Maternal-Fetal AttachmentTurkey (Türkiye)
-
Danone NutriciaCompletedBreast Feeding | Breast Milk ExpressionChina
-
University of TurkuCompleted
-
Sakarya UniversityNot yet recruitingBreast Feeding | Feeding BehaviorTurkey
-
University of Maryland, BaltimoreWithdrawnBreast Pumping | Human Milk/BreastfeedingUnited States
-
Cumhuriyet UniversityCumhuriyet University HospitalCompletedBreast-feeding | Kangaroo Care | Comfort in Neonates | Pain in NewbornsTurkey (Türkiye)
Clinical Trials on Massage
-
University of TromsoRecruitingChronic Neck PainNorway
-
Chulalongkorn UniversityCompletedIschemic StrokeThailand
-
Mayo ClinicCompletedFatigue | Stress | Anxiety | TensionUnited States
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
muxing zhuRecruiting
-
EMRE ERKALCompleted
-
Mersin UniversityCompletedHemodialysis PatientsTurkey
-
Universitat Internacional de CatalunyaUnknown
-
University Hospital, ToulouseCompleted
-
Hakkari UniversitesiActive, not recruitingMyocardial Infarction | Angina PectorisTurkey