Breast FeedingNCT06536608
The Effect of Oketani Breast Massage on Breastfeeding
A study testing Massage in people with Breast Feeding and Massage, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Massage
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2024to 20 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cankiri State Hospital
Çankırı
Sakine Yılmaz, PhD
About this study
Official title: The Effect of Oketani Breast Massage on Breastfeeding Success, Breastfeeding Self-Efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial
This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.
Read the detailed description
Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings and massage should be given starting from the prenatal period. It is important for health professionals to provide training and consultancy to women in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that correct breastfeeding behavior and self-sufficiency will be developed in mothers by using the oketani breast massage method. No study has been found in our country where this method is used. In this respect, the study is original. As a result of the study, it is thought that the use of oketani breast massage by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.
- Conditions
- Breast Feeding, Massage
- Being tested
- Massage
- Keywords
- Breast Feeding, Nursing, Massage
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Also called Oketani Massage
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage Group | Experimental | 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. Receives: Other: Massage |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form
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.
Measured: 1. week, 2. week and after labor 1. day
Secondary outcomes (1)
Visual Assessment Scale - Satisfaction (VAS - S)
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
Measured: After labor 1. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start4 Nov 2024
- Primary completion4 May 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with oketani massage group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Ünal Toprak, Saglik Bilimleri Universitesi
- Investigators
- Filiz Ünal Toprak, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536608
- Sponsor's protocol ID
- FÜT-02
- Status last verified
- Nov 2024
- First submitted
- 26 Jul 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oketani Breast Massage on Breastfeeding Success, Breastfeeding Self-Efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06536608
- Acronym / sponsor ID
- FÜT-02
- Conditions
- Breast Feeding, Massage
- Keywords
- Breast Feeding, Nursing, Massage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 4 May 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.
Detailed description
Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings and massage should be given starting from the prenatal period. It is important for health professionals to provide training and consultancy to women in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that correct breastfeeding behavior and self-sufficiency will be developed in mothers by using the oketani breast massage method. No study has been found in our country where this method is used. In this respect, the study is original. As a result of the study, it is thought that the use of oketani breast massage by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with oketani massage group and control group
| Arm | Type | Receives |
|---|---|---|
| Massage Group | Experimental | Other: MassagePregnant 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageAlso: Oketani MassageThe 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 | Massage Group |
Primary outcome
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 secondary outcome
Visual Assessment Scale - Satisfaction (VAS - S)
Time frame: After labor 1. day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filiz Ünal Toprak, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Breast Feeding and Massage, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filiz Ünal Toprak, PhD (05077732090, filizore1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form (time frame: 1. week, 2. week and after labor 1. day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.