BreastfeedingOKETANI-BFNCT07354360
Effect of Oketani Breast Massage on Promoting Breastfeeding
A study testing Oketani massage group in people with Breastfeeding and Breastfeeding Self-Efficacy, run by Mansoura University at 1 site in Egypt.
Trial summary
Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Breastfeeding, Breastfeeding Self-Efficacy, Oketani Massage
- What is being tested?
- Oketani massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Dec 2026
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 35 years
- Singleton pregnancy
- Term gestation (>37-40 weeks).
- Women willing to breast feed
- The woman will deliver by cesarean section and has relative with her
- Absence of maternal physical and/ or mental illness that prevents breastfeeding.
Show all 10Show fewer
- The exclusion criteria include:
- Women with breast problems such as breast tumors, breast surgery and nipple problems
- Women have obstetric complications as postpartum hemorrhage.
- Neonatal problems
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura University
Al Mansurah, 335516
Nourhan Magdy Nasr, MSc in woman's health and midw, 01097316731, docnourhan74@gmail.com
About this study
Official title: Effect of Oketani Massage on Successful Breastfeeding
Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful breastfeeding. Oketani massage is a non-pharmacological, cost-effective breast massage technique developed to enhance milk flow, improve maternal comfort during breastfeeding and reduce breast engorgement. This study aims to evaluate effect of Oketani massage on successful breastfeeding. Successful breastfeeding will be assessed through indicators of maternal latching technique, successful breastfeeding behavior and maternal breastfeeding self-efficacy. The findings of this study may support the use of Oketani massage as a supportive nursing intervention to promote successful breastfeeding outcomes in the early postpartum period
- Conditions
- Breastfeeding, Breastfeeding Self-Efficacy, Oketani Massage, Latching
- Being tested
- Oketani massage group
- Keywords
- Breastfeeding, Oketani massage, breastfeeding self-efficacy, breast engorgement, Feeding Behavior
- Medical subject headings
- Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oketani massage groupOther
primipara who meet inclusion criteria and who are assigned to the intervention group will be informed about the study and their consent will be obtained.. Primipara mothers in the intervention group will receive Oketani massage after delivery to enhance successful breastfeeding. The massage is performed using 8 specific hand steps (7 steps for separating the mammary glands and 1 step for expression). Each session lasts 15-20 minutes and is repeated according to the study protocol. the researcher will train primipara relatives to apply Oketani massage after discharge to primipara after discharge. The massage aims to increase milk flow, reduce breast engorgement, improve breast softness, enhance nipple elasticity, and increase maternal comfort and breastfeeding self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | This group will receive the Oketani massage. Receives: Other: Oketani massage group |
| Control group | No intervention | Primipara women in the control group who meet the inclusion criteria will be informed about the study and their consent will be obtained. This group will receive postpartum routine breast care according to health care facility policy. and they will be assessed according to outcome measures in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The LATCH Assessment sheet
It will be adopted from (Jensen et al, 1994) to assess primipara women's need for breastfeeding support, it is numbered from zero to ten, and getting a score of less than ten offers the women's need for more support during breastfeeding. The letters of the acronym LATCH appoint separate areas of assessment: L (Latch) for how well the infant latches onto the breast; A (Audible swallowing) refers the amount of audible swallowing noted while nursing the neonate; T (Type of nipple) for the women's nipple type; C (Comfort) for the women's level of comfort regarding the breast and nipple; and H (Hold) indicates to whether or not the women need help in positioning the infant.
Scoring system:
The system assigns a numerical score, 0, 1, or 2, to five key statements. LATCH score of poor (0 to 3), moderate (4 to 7), and good (8 to 10)
Measured: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
Secondary outcomes (1)
Infant Breastfeeding Assessment Tool (IBFAT).
It will be adopted from (Matthews, 1988) to assess the infant state and contains four statements as the following: (1) infant readiness to feed/reusability, (2) rooting, (3) fixing (the time needed to latch to the breast), and (4) the sucking pattern.
Scoring system:
Each item is scored on a scale of 0-3, with minimum and maximum scores of 0 to 12, respectively. A score of 10-12 refers to completely successful breastfeeding behavior, a score of 7-9 indicates relatively successful breastfeeding behavior and a score of 0-6 suggests unsuccessful breastfeeding behavior.
Measured: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * The massage will be performed very gently and rhythmically on the right and left breasts within 8 several manual steps. From one to seven refers to (the course of treatment) \& Step eight refers to (milking or expressing). * One minute will be spent on a series of tasks and statements, which will be repeated for 15 to 20 minutes. Pushing and pulling away included manipulations in stages one, two, and three will be carried out gently and painlessly on primipara women in order to separate the hard section of the breast from the fascia of the pectoralis. Four to six steps will be required to drag the entire breast downward and to either side with two thumbs and two hands. At four Steps; the total breast will be pushed down towards the umbilicus. Five to six steps will be done to disconnect the hard base parts of the breast. In addition to, the breast will be circulated clockwise in the first seven steps with an expansion of its base. In the eighth step, expression will be done
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasr, Principal investigator, Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354360
- Sponsor's protocol ID
- NURS-MU-OKETANI-2026
- Acronym
- OKETANI-BF
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oketani Massage on Successful Breastfeeding
- ClinicalTrials.gov ID
- NCT07354360
- Acronym / sponsor ID
- OKETANI-BF / NURS-MU-OKETANI-2026
- Conditions
- Breastfeeding, Breastfeeding Self-Efficacy, Oketani Massage, Latching
- Keywords
- Breastfeeding, Oketani massage, breastfeeding self-efficacy, breast engorgement, Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful breastfeeding. Oketani massage is a non-pharmacological, cost-effective breast massage technique developed to enhance milk flow, improve maternal comfort during breastfeeding and reduce breast engorgement. This study aims to evaluate effect of Oketani massage on successful breastfeeding. Successful breastfeeding will be assessed through indicators of maternal latching technique, successful breastfeeding behavior and maternal breastfeeding self-efficacy. The findings of this study may support the use of Oketani massage as a supportive nursing intervention to promote successful breastfeeding outcomes in the early postpartum period
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * The massage will be performed very gently and rhythmically on the right and left breasts within 8 several manual steps. From one to seven refers to (the course of treatment) \& Step eight refers to (milking or expressing). * One minute will be spent on a series of tasks and statements, which will be repeated for 15 to 20 minutes. Pushing and pulling away included manipulations in stages one, two, and three will be carried out gently and painlessly on primipara women in order to separate the hard section of the breast from the fascia of the pectoralis. Four to six steps will be required to drag the entire breast downward and to either side with two thumbs and two hands. At four Steps; the total breast will be pushed down towards the umbilicus. Five to six steps will be done to disconnect the hard base parts of the breast. In addition to, the breast will be circulated clockwise in the first seven steps with an expansion of its base. In the eighth step, expression will be done
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Oketani massage groupThis group will receive the Oketani massage. |
| Control group | No intervention | –Primipara women in the control group who meet the inclusion criteria will be informed about the study and their consent will be obtained. This group will receive postpartum routine breast care according to health care facility policy. and they will be assessed according to outcome measures in the study |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 35 years
- Singleton pregnancy
- Term gestation (>37-40 weeks).
- Women willing to breast feed
- The woman will deliver by cesarean section and has relative with her
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oketani massage groupprimipara who meet inclusion criteria and who are assigned to the intervention group will be informed about the study and their consent will be obtained.. Primipara mothers in the intervention group will receive Oketani massage after delivery to enhance successful breastfeeding. The massage is performed using 8 specific hand steps (7 steps for separating the mammary glands and 1 step for expression). Each session lasts 15-20 minutes and is repeated according to the study protocol. the researcher will train primipara relatives to apply Oketani massage after discharge to primipara after discharge. The massage aims to increase milk flow, reduce breast engorgement, improve breast softness, enhance nipple elasticity, and increase maternal comfort and breastfeeding self-efficacy. | Other | Intervention group |
Primary outcome
The LATCH Assessment sheet
Time frame: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
It will be adopted from (Jensen et al, 1994) to assess primipara women's need for breastfeeding support, it is numbered from zero to ten, and getting a score of less than ten offers the women's need for more support during breastfeeding. The letters of the acronym LATCH appoint separate areas of assessment: L (Latch) for how well the infant latches onto the breast; A (Audible swallowing) refers the amount of audible swallowing noted while nursing the neonate; T (Type of nipple) for the women's nipple type; C (Comfort) for the women's level of comfort regarding the breast and nipple; and H (Hold) indicates to whether or not the women need help in positioning the infant. Scoring system: The system assigns a numerical score, 0, 1, or 2, to five key statements. LATCH score of poor (0 to 3), moderate (4 to 7), and good (8 to 10)
1 secondary outcome
Infant Breastfeeding Assessment Tool (IBFAT).
Time frame: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Nasr principal investigator
Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oketani massage group in people with Breastfeeding and Breastfeeding Self-Efficacy, run by Mansoura University at 1 site in Egypt.
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 10 inclusion and 0 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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 Egypt. 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 Nourhan Magdy Nasr, MSc in woman's health and midw (01097316731, docnourhan74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The LATCH Assessment sheet (time frame: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)). 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 10 Mar 2026.