BreastfeedingNCT05903846
The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section
A study testing Oketani massage in people with Breastfeeding and Engorgement of Breast Associated With Childbirth, Postpartum, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Engorgement of Breast Associated With Childbirth, Postpartum
- What is being tested?
- Oketani massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Delivery by cesarean section
- Single and live birth,
- 38-40 Giving birth between weeks
- Not having a mental or physical disability that prevents breastfeeding,
- The baby does not need neonatal intensive care
- The baby does not have a condition that prevents breastfeeding
- Sharing the same room with the baby
- Agreeing to participate in the research
Who cannot join
- Refusal to participate in the study
- Giving birth normally
- Giving birth prematurely
- Having a mental and physical disability that prevents breastfeeding
- Being 18 years of age or younger
- Transferring the baby to the neonatal intensive care unit
- Having a condition that prevents breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section: A Randomized Controlled Study
The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. The universe of the study consisted of mothers who were hospitalized in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023 and gave birth by cesarean section. The Open Epi calculation tool was used to determine the sample of the study. The sample calculation was made on the average score differences in the Open Epi info program. Accordingly, it was planned to include 106 mothers, 53 of whom were in the control group and 53 in the massage group. Considering the sample loss to be experienced during data collection, a total of 116 mothers, 58 in the control group and 58 in the massage group, were included in the study. Randomization of the groups participating in the study was made as simple randomization using the www.random.org site. Introductory Characteristics Questionnaire, oketany massage follow-up form, breast engorgement assessment scale and LATCH breastfeeding diagnostic measurement tool were used to collect the research data.
Read the detailed description
The research was carried out in two groups, namely the octopus massage group and the control group.
Oketani Massage Group: According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast engorgement and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale. Control Group: No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast engorgement a and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale.
- Being tested
- Oketani massage
- Keywords
- breastfeeding, Engorgement, Oketani massage
- Medical subject headings
- Breast Feeding, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oketani massageOther
The part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless.
| Study group | Role | What they receive |
|---|---|---|
| Oketani massage group | Experimental | According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast engorgement assessment scale and the LATCH breastfeeding diagnostic scale. Receives: Other: Oketani massage |
| Control group | No intervention | No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast fengorgement assessment scale and the LATCH breastfeeding diagnostic scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast engorgement assessment scale
The scale is scored from 1 to 6. On the scale, "1" is evaluated as no soft change, while "6" is expressed as very hard and very sensitive. If the score from the scale is higher than 4, it means that there is breast fullness.
Measured: postpartum 48 hours from birth
LATCH breastfeeding diagnostic scale
by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.
Measured: postpartum 48 hours from birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oketani massage,The part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless. There are 8 different stages in massage. Each set lasts 1 minute, the massage continues for 15-20 minutes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Serap ÇAĞAN, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903846
- Sponsor's protocol ID
- AgriIbrahimCecenU
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 10 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05903846
- Acronym / sponsor ID
- AgriIbrahimCecenU
- Keywords
- breastfeeding, Engorgement, Oketani massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Jun 2023 (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.
The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. The universe of the study consisted of mothers who were hospitalized in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023 and gave birth by cesarean section. The Open Epi calculation tool was used to determine the sample of the study. The sample calculation was made on the average score differences in the Open Epi info program. Accordingly, it was planned to include 106 mothers, 53 of whom were in the control group and 53 in the massage group. Considering the sample loss to be experienced during data collection, a total of 116 mothers, 58 in the control group and 58 in the massage group, were included in the study. Randomization of the groups participating in the study was made as simple randomization using the www.random.org site. Introductory Characteristics Questionnaire, oketany massage follow-up form, breast engorgement assessment scale and LATCH breastfeeding diagnostic measurement tool were used to collect the research data.
Detailed description
The research was carried out in two groups, namely the octopus massage group and the control group.
Oketani Massage Group: According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast engorgement and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale. Control Group: No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast engorgement a and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Oketani massage,The part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless. There are 8 different stages in massage. Each set lasts 1 minute, the massage continues for 15-20 minutes.
| Arm | Type | Receives |
|---|---|---|
| Oketani massage group | Experimental | Other: Oketani massageAccording to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast engorgement assessment scale and the LATCH breastfeeding diagnostic scale. |
| Control group | No intervention | –No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast fengorgement assessment scale and the LATCH breastfeeding diagnostic scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Delivery by cesarean section
- Single and live birth,
- 38-40 Giving birth between weeks
- Not having a mental or physical disability that prevents breastfeeding,
- The baby does not need neonatal intensive care
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Giving birth normally
- Giving birth prematurely
- Having a mental and physical disability that prevents breastfeeding
- Being 18 years of age or younger
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 massageThe part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless. | Other | Oketani massage group |
Primary outcome
Breast engorgement assessment scale
Time frame: postpartum 48 hours from birth
The scale is scored from 1 to 6. On the scale, "1" is evaluated as no soft change, while "6" is expressed as very hard and very sensitive. If the score from the scale is higher than 4, it means that there is breast fullness.
LATCH breastfeeding diagnostic scale
Time frame: postpartum 48 hours from birth
by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Breastfeeding and Engorgement of Breast Associated With Childbirth, Postpartum, run by Agri Ibrahim Cecen University 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 10 Feb 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast engorgement assessment scale (time frame: postpartum 48 hours from birth). The study lists 2 primary outcomes in all. 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 Feb 2026.