Breastfeeding, ExclusiveOMNCT06242886
After Caesarean Section Oxitocin Breast Massage Anthropometric Characteristics of the Newborn
A study testing Oxytocin massage and and Breast massage in people with Breastfeeding, Exclusive and Breastfeeding, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Breastfeeding
- What is being tested?
- Oxytocin massage and and Breast massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 20 Sep 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study included mothers between the ages of 18 and 35, who were primiparous, due (37-42 GW) and cesarean section, who could understand and speak Turkish, who had no anatomical problems with their breasts, and who were in the first 24 hours after birth.
Who cannot join
- Mothers with communication problems, having a chronic illness, breastfeeding related problems (breast or newborn) and mothers with newborns with IUGR or genetic disease were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxytocin Massage After Caesarean Section on Anthropometric Characteristics of the Newborn and Breastfeeding Self-Efficacy: A Single Blind, Randomized Controlled Study
Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy.
Research Aims: The aim of this study was to investigate the effect of breast and oxytocin massage after cesarean section on the anthropometric characteristics of the newborn and breastfeeding self-efficacy.
Methods: The study was conducted in a single-blind randomized controlled type and 126 mothers who delivered by cesarean section in the postpartum department of a private hospital in Istanbul/Turkey were randomized into three groups as 42 breast massage, 42 oxytocin massage and 42 control group.
Read the detailed description
Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy.
Research Aims: The aim of this study was to investigate the effect of breast and oxytocin massage after cesarean section on the anthropometric characteristics of the newborn and breastfeeding self-efficacy.
Methods: The study was conducted in a single-blind randomized controlled type and 126 mothers who delivered by cesarean section in the postpartum department of a private hospital in Istanbul/Turkey were randomized into three groups as 42 breast massage, 42 oxytocin massage and 42 control group.
Mothers who had a cesarean delivery and were in the first 24 hours after birth were divided into three separate groups: breast massage, oxytocin massage and control group. Data Collection Form, LACTH, Infant Follow-up Form and Breastfeeding Self-Efficacy Scale were applied to all mothers included in the sampling in the postpartum period.
Oxytocin massage group: The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours.
Breast massage group: The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours.
Control group: Mothers were discontinued from routine care at the clinic.
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Being tested
- Oxytocin massage, and Breast massage
- Keywords
- Breastfeeding self-efficacy, C-section,, oxytocin
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin massageBehavioural
Oxytocin massage group: The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours.
and Breast massageBehavioural
Breast massage group: The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin massage | Experimental | The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours. Receives: Behavioral: Oxytocin massage |
| Breast massage | Experimental | The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours. Receives: Behavioral: and Breast massage |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
Breastfeeding Self-Efficacy Scale Total Score; Breastfeeding Charting System (LATCH) Turkish validity and reliability were made by Yenal and Okumuş [12]. Scale was developed to evaluate the breastfeeding. On the LATCH scale, a score of 0, 1 or 2 is given for each criterion. A minimum of 0-Maximum score of 10 points is taken from the scale. A low score by the mother indicates that she needs help with breastfeeding. Scoring is done by observing breastfeeding.
Measured: Three times=immediately after birth, the first 24 hours after birth, and the 7th day after birth
Breastfeeding success
Breastfeeding success (LATCH) total score; As the LATCH score increases, it is understood that breastfeeding success is high. LATCH Cronbach's Alpha value: It was found to be 0.95 by Yenal and Okumuş [12]. In this study, 0.86 found. Developed to evaluate the breastfeeding self-efficacy levels of mothers. The Breastfeeding Self-Efficacy Short Form Scale is a Likert-type scale with 5 points. The minimum score that can be taken from the scale is 14 and the maximum score is 70. The higher the score, the higher the breastfeeding shows self-efficacy. The Turkish validity and reliability study of the scale was conducted by Tokat et al.[13] and Cronbach's Alpha value was found to be 0.86
Measured: Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth
Newborn Anthropometric Characteristics
Weight
Measured: Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Feb 2023
- Primary completion20 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies 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
- A Single Blind, Randomized Controlled Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242886
- Sponsor's protocol ID
- Massage
- Acronym
- OM
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin Massage After Caesarean Section on Anthropometric Characteristics of the Newborn and Breastfeeding Self-Efficacy: A Single Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06242886
- Acronym / sponsor ID
- OM / Massage
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Keywords
- Breastfeeding self-efficacy, C-section,, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 5 Feb 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.
Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy.
Research Aims: The aim of this study was to investigate the effect of breast and oxytocin massage after cesarean section on the anthropometric characteristics of the newborn and breastfeeding self-efficacy.
Methods: The study was conducted in a single-blind randomized controlled type and 126 mothers who delivered by cesarean section in the postpartum department of a private hospital in Istanbul/Turkey were randomized into three groups as 42 breast massage, 42 oxytocin massage and 42 control group.
Detailed description
Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy.
Research Aims: The aim of this study was to investigate the effect of breast and oxytocin massage after cesarean section on the anthropometric characteristics of the newborn and breastfeeding self-efficacy.
Methods: The study was conducted in a single-blind randomized controlled type and 126 mothers who delivered by cesarean section in the postpartum department of a private hospital in Istanbul/Turkey were randomized into three groups as 42 breast massage, 42 oxytocin massage and 42 control group.
Mothers who had a cesarean delivery and were in the first 24 hours after birth were divided into three separate groups: breast massage, oxytocin massage and control group. Data Collection Form, LACTH, Infant Follow-up Form and Breastfeeding Self-Efficacy Scale were applied to all mothers included in the sampling in the postpartum period.
Oxytocin massage group: The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours.
Breast massage group: The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours.
Control group: Mothers were discontinued from routine care at the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Single Blind, Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Oxytocin massage | Experimental | Behavioral: Oxytocin massageThe mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours. |
| Breast massage | Experimental | Behavioral: and Breast massageThe mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included mothers between the ages of 18 and 35, who were primiparous, due (37-42 GW) and cesarean section, who could understand and speak Turkish, who had no anatomical problems with their breasts, and who were in the first 24 hours after birth.
Key exclusion criteria (1 listed)
- Mothers with communication problems, having a chronic illness, breastfeeding related problems (breast or newborn) and mothers with newborns with IUGR or genetic disease were not included in the study.
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 |
|---|---|---|
| Oxytocin massageOxytocin massage group: The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours. | Behavioural | Oxytocin massage |
| and Breast massageBreast massage group: The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours. | Behavioural | Breast massage |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: Three times=immediately after birth, the first 24 hours after birth, and the 7th day after birth
Breastfeeding Self-Efficacy Scale Total Score; Breastfeeding Charting System (LATCH) Turkish validity and reliability were made by Yenal and Okumuş [12]. Scale was developed to evaluate the breastfeeding. On the LATCH scale, a score of 0, 1 or 2 is given for each criterion. A minimum of 0-Maximum score of 10 points is taken from the scale. A low score by the mother indicates that she needs help with breastfeeding. Scoring is done by observing breastfeeding.
Breastfeeding success
Time frame: Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth
Breastfeeding success (LATCH) total score; As the LATCH score increases, it is understood that breastfeeding success is high. LATCH Cronbach's Alpha value: It was found to be 0.95 by Yenal and Okumuş [12]. In this study, 0.86 found. Developed to evaluate the breastfeeding self-efficacy levels of mothers. The Breastfeeding Self-Efficacy Short Form Scale is a Likert-type scale with 5 points. The minimum score that can be taken from the scale is 14 and the maximum score is 70. The higher the score, the higher the breastfeeding shows self-efficacy. The Turkish validity and reliability study of the scale was conducted by Tokat et al.[13] and Cronbach's Alpha value was found to be 0.86
Newborn Anthropometric Characteristics
Time frame: Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth
Weight
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 5 Feb 2024.
- 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 Oxytocin massage and and Breast massage in people with Breastfeeding, Exclusive and Breastfeeding, run by Halic 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 1 inclusion and 1 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 5 Feb 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?
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?
Breastfeeding Self-Efficacy (time frame: Three times=immediately after birth, the first 24 hours after birth, and the 7th day after birth). The study lists 3 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 5 Feb 2024.