Breast FeedingNCT05806892
The Effect of Warm Application to the Breast With the Aid of Thera Pearl on Milk Release and Breastfeeding Success
A study testing Thera Pearl in people with Breast Feeding, run by Amasya University.
Trial summary
Breastfeeding and breast milk are very important in supporting newborn growth and development. The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that breastfeeding should be continued with only breast milk for the first 6 months after birth and with complementary foods until… 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
- What is being tested?
- Thera Pearl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2023to 15 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a primary school graduate
- be over 18 years old
- Living in the city center of Amasya
- Being primiparous
- Being open to communication
- Those who volunteered to participate in the research
- Those with normal mental health
Who cannot join
- not willing to participate in research
- have any disease
- those who are not with the baby
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Warm Application to the Breast With the Help of Thera Pearl in the Postpartum Period on Milk Release, Breastfeeding Success of Mothers, Milk Perception and Postpartum Breastfeeding Self-Efficacy: A Randomized Controlled Study
Breastfeeding and breast milk are very important in supporting newborn growth and development. The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that breastfeeding should be continued with only breast milk for the first 6 months after birth and with complementary foods until the age of 2 years. However, the rate of breastfeeding all over the world is far from the targeted values. For this reason, it is necessary to plan and implement various interventions in order to start breastfeeding in the early period and to help maintain breastfeeding.
There are various problems associated with breastfeeding. Large, sunken or flat nipples, tongue-tie in the fetus, excessive milk production, lack of milk production or late onset are some of these problems. It is known that the most common problems are breast fullness or late onset of milk production. In both cases, early resolution is important in ensuring the sustainability of breastfeeding. During the breastfeeding period, various applications are used in order to both relieve fullness and increase milk production. Applying hot water to the udder is the most preferred way to increase milk production. The fact that it does not require much cost, does not contain any herbal or pharmacological agents and is easy to apply, as well as relieving the fullness of the breasts for the mother and increasing milk production, increases the popularity of hot water application. When the relevant literature was reviewed, it was seen that the hot application to the breast was generally done through a warm towel or hot water bag, but there was no study using Thera Pearl.
This study will be carried out in an experimental design in order to evaluate the effect of warm application applied to the breast with the help of Thera Pearl in the postpartum period on milk release, breastfeeding success of mothers, milk perception and postpartum breastfeeding self-efficacy. The research will be carried out in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital obstetrics service between April and September 2023. Personal Information Form, Breastfeeding Observation Form, Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be used to collect data. It is thought that the application to be made for breastfeeding problems and milk release will be effective.
Read the detailed description
Breastfeeding and breast milk are very important in the protection and development of maternal and newborn health. Breast milk is a nutrient with unique immunological and anti-inflammatory properties that protect against many diseases. The World Health Organization and the United Nations Children's Fund recommend continuing breastfeeding with appropriate complementary foods until the age of 2, without any additional food for the first six months after birth, as the first condition of a healthy diet.
The World Health Organization announced that the rate of exclusive breastfeeding in the first six months is 44% worldwide in 2020. UNICEF reported that one in five babies in high-income countries and one in 25 babies in low- and middle-income countries are not breastfed at all.
Breastfeeding problems may occur for various reasons in the postpartum period. Breast fullness or late onset of milk production are among the most common of these problems. In cases where milk production is too high, breast fullness can be experienced, while milk production can be very slow in the opposite case. In both cases, early resolution is important in ensuring the sustainability of breastfeeding. The absence or late onset of milk production after birth causes the mother to be alarmed, interruption of breastfeeding, and ultimately feeding the newborn with formula. In the first 6 months of life, when the baby should receive only breast milk, feeding with formulas other than breast milk or different nutrients is an issue that needs to be addressed as it will adversely affect its growth and development. In this sense, milk production should be supported by making use of non-pharmacological methods in the postpartum period. Massage, herbal agents or hot water application are often preferred to increase milk production. Applying hot water to the udder is the most preferred way to increase milk production. The fact that it does not require much cost, does not contain any herbal or pharmacological agents and is easy to apply, also relieves the fullness of the breasts for the mother and increases milk production, increases the popularity of hot water application. As a matter of fact, in a study, it was determined that women who applied hot water to the nipples in the first 10 days after giving birth experienced less pain. When the relevant literature was reviewed, it was seen that there was no study using Thera Pearl, in which the warm application to the breast was usually done through a warm towel or hot water bag.
For the experimental group:
The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that there will be a home visit on days.
Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital.
Then the participant is postpartum 2-7. on days and 10-15. They will be visited at home once a day and their status of applying Thera Pearl will be questioned. In addition, the Breastfeeding Observation Form (for postpartum days 2-7 and 10-15), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled again.
For the control group:
No intervention will be applied to the control group. The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that home visits will be made on the following days.
Then the participant is postpartum 2-7. and 10-15. Breastfeeding Observation Form (for postpartum days 2-7 and 10-15), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled in once a day.
- Conditions
- Breast Feeding
- Being tested
- Thera Pearl
- Keywords
- postpartum period, Thera Pearl, Breastfeeding Self-Efficacy, randomized controlled trial
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thera PearlOther
You can apply Thera°Pearl warm breast therapy before breastfeeding or during milking. You should do this application 4 times a day, in the morning, at noon, in the evening and at night before going to bed. Each application should be done on both breasts and should last at least 20 minutes.
Thera°Pearl Warm Breast Therapy has been developed to open milk ducts and accelerate milk flow.
Thermogel packs for Thera°Pearl hot therapy can be heated inside the fabric covers in the microwave for a maximum of 15 seconds or in hot water by removing the fabric covers. Packages that have been removed from the cover should be kept in boiling water for 1-2 minutes and then applied by putting them into the sheath.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital. Receives: Other: Thera Pearl |
| Control | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Breastfeeding Assessment Tool (BBAT):
BBAT: The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Measured: within 24 hours of postpartum
Breast-feeding Self-efficacy Scale (BSS)
BSS: The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Measured: within 24 hours of postpartum
Poor Milk Perception Scale (PMPS):
PMPS: A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Measured: within 24 hours of postpartum
Evaluation of Thera Pearl application 1
Bristol Breastfeeding Assessment Tool (BBAT): The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Measured: within 2-7 days postpartum
Evaluation of Thera Pearl application 2
Breast-feeding Self-efficacy Scale (BSS): The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Measured: within 2-7 days postpartum
Evaluation of Thera Pearl application 3
Poor Milk Perception Scale (PMPS): A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Measured: within 2-7 days postpartum
Evaluation of Thera Pearl application 1
Bristol Breastfeeding Assessment Tool (BBAT): The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Measured: within 10-15 days postpartum
Evaluation of Thera Pearl application 2
Breast-feeding Self-efficacy Scale (BSS): The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Measured: within 10-15 days postpartum
Evaluation of Thera Pearl application 3
Poor Milk Perception Scale (PMPS): A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Measured: within 10-15 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start24 Jul 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion15 Sep 2023 (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.
- 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
- The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that there will be a home visit on days. Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital. Then the participant is postpartum 2-7. on days and 10-15. They will be visited at home once a day and their status of applying Thera Pearl will be questioned. The final test will be applied.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
- Investigators
- Hava Özkan, Özkan, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806892
- Sponsor's protocol ID
- AmasyaU-betuluzun-002
- Status last verified
- Jul 2023
- First submitted
- 11 Mar 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to publish the obtained data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warm Application to the Breast With the Help of Thera Pearl in the Postpartum Period on Milk Release, Breastfeeding Success of Mothers, Milk Perception and Postpartum Breastfeeding Self-Efficacy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05806892
- Acronym / sponsor ID
- AmasyaU-betuluzun-002
- Conditions
- Breast Feeding
- Keywords
- postpartum period, Thera Pearl, Breastfeeding Self-Efficacy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 24 Jul 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 10 Apr 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.
Breastfeeding and breast milk are very important in supporting newborn growth and development. The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that breastfeeding should be continued with only breast milk for the first 6 months after birth and with complementary foods until the age of 2 years. However, the rate of breastfeeding all over the world is far from the targeted values. For this reason, it is necessary to plan and implement various interventions in order to start breastfeeding in the early period and to help maintain breastfeeding.
There are various problems associated with breastfeeding. Large, sunken or flat nipples, tongue-tie in the fetus, excessive milk production, lack of milk production or late onset are some of these problems. It is known that the most common problems are breast fullness or late onset of milk production. In both cases, early resolution is important in ensuring the sustainability of breastfeeding. During the breastfeeding period, various applications are used in order to both relieve fullness and increase milk production. Applying hot water to the udder is the most preferred way to increase milk production. The fact that it does not require much cost, does not contain any herbal or pharmacological agents and is easy to apply, as well as relieving the fullness of the breasts for the mother and increasing milk production, increases the popularity of hot water application. When the relevant literature was reviewed, it was seen that the hot application to the breast was generally done through a warm towel or hot water bag, but there was no study using Thera Pearl.
This study will be carried out in an experimental design in order to evaluate the effect of warm application applied to the breast with the help of Thera Pearl in the postpartum period on milk release, breastfeeding success of mothers, milk perception and postpartum breastfeeding self-efficacy. The research will be carried out in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital obstetrics service between April and September 2023. Personal Information Form, Breastfeeding Observation Form, Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be used to collect data. It is thought that the application to be made for breastfeeding problems and milk release will be effective.
Detailed description
Breastfeeding and breast milk are very important in the protection and development of maternal and newborn health. Breast milk is a nutrient with unique immunological and anti-inflammatory properties that protect against many diseases. The World Health Organization and the United Nations Children's Fund recommend continuing breastfeeding with appropriate complementary foods until the age of 2, without any additional food for the first six months after birth, as the first condition of a healthy diet.
The World Health Organization announced that the rate of exclusive breastfeeding in the first six months is 44% worldwide in 2020. UNICEF reported that one in five babies in high-income countries and one in 25 babies in low- and middle-income countries are not breastfed at all.
Breastfeeding problems may occur for various reasons in the postpartum period. Breast fullness or late onset of milk production are among the most common of these problems. In cases where milk production is too high, breast fullness can be experienced, while milk production can be very slow in the opposite case. In both cases, early resolution is important in ensuring the sustainability of breastfeeding. The absence or late onset of milk production after birth causes the mother to be alarmed, interruption of breastfeeding, and ultimately feeding the newborn with formula. In the first 6 months of life, when the baby should receive only breast milk, feeding with formulas other than breast milk or different nutrients is an issue that needs to be addressed as it will adversely affect its growth and development. In this sense, milk production should be supported by making use of non-pharmacological methods in the postpartum period. Massage, herbal agents or hot water application are often preferred to increase milk production. Applying hot water to the udder is the most preferred way to increase milk production. The fact that it does not require much cost, does not contain any herbal or pharmacological agents and is easy to apply, also relieves the fullness of the breasts for the mother and increases milk production, increases the popularity of hot water application. As a matter of fact, in a study, it was determined that women who applied hot water to the nipples in the first 10 days after giving birth experienced less pain. When the relevant literature was reviewed, it was seen that there was no study using Thera Pearl, in which the warm application to the breast was usually done through a warm towel or hot water bag.
For the experimental group:
The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that there will be a home visit on days.
Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital.
Then the participant is postpartum 2-7. on days and 10-15. They will be visited at home once a day and their status of applying Thera Pearl will be questioned. In addition, the Breastfeeding Observation Form (for postpartum days 2-7 and 10-15), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled again.
For the control group:
No intervention will be applied to the control group. The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that home visits will be made on the following days.
Then the participant is postpartum 2-7. and 10-15. Breastfeeding Observation Form (for postpartum days 2-7 and 10-15), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled in once a day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The first interview with women who gave birth will be held in the postpartum service of the relevant hospital. In this interview, Personal Information Form, Breastfeeding Observation Form (for the first 24 hours after birth), Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be filled. At the same time, the phone and address information of the participants will be obtained in this meeting, and the postpartum 2-7. and 10-15. You will be informed that there will be a home visit on days. Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital. Then the participant is postpartum 2-7. on days and 10-15. They will be visited at home once a day and their status of applying Thera Pearl will be questioned. The final test will be applied.
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Thera PearlThera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital. |
| Control | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being a primary school graduate
- be over 18 years old
- Living in the city center of Amasya
- Being primiparous
- Being open to communication
Key exclusion criteria (3 listed)
- not willing to participate in research
- have any disease
- those who are not with the baby
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 |
|---|---|---|
| Thera PearlYou can apply Thera°Pearl warm breast therapy before breastfeeding or during milking. You should do this application 4 times a day, in the morning, at noon, in the evening and at night before going to bed. Each application should be done on both breasts and should last at least 20 minutes. Thera°Pearl Warm Breast Therapy has been developed to open milk ducts and accelerate milk flow. Thermogel packs for Thera°Pearl hot therapy can be heated inside the fabric covers in the microwave for a maximum of 15 seconds or in hot water by removing the fabric covers. Packages that have been removed from the cover should be kept in boiling water for 1-2 minutes and then applied by putting them into the sheath. | Other | Experiment |
Primary outcome
Bristol Breastfeeding Assessment Tool (BBAT):
Time frame: within 24 hours of postpartum
BBAT: The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Breast-feeding Self-efficacy Scale (BSS)
Time frame: within 24 hours of postpartum
BSS: The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Poor Milk Perception Scale (PMPS):
Time frame: within 24 hours of postpartum
PMPS: A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Evaluation of Thera Pearl application 1
Time frame: within 2-7 days postpartum
Bristol Breastfeeding Assessment Tool (BBAT): The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Evaluation of Thera Pearl application 2
Time frame: within 2-7 days postpartum
Breast-feeding Self-efficacy Scale (BSS): The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Evaluation of Thera Pearl application 3
Time frame: within 2-7 days postpartum
Poor Milk Perception Scale (PMPS): A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Evaluation of Thera Pearl application 1
Time frame: within 10-15 days postpartum
Bristol Breastfeeding Assessment Tool (BBAT): The scale consists of 4 items. Each item is scored between 0-2 points. For each item, 0 points/poor, 1 point/moderate, 2 points/good are evaluated. The lowest score obtained from the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Evaluation of Thera Pearl application 2
Time frame: within 10-15 days postpartum
Breast-feeding Self-efficacy Scale (BSS): The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Evaluation of Thera Pearl application 3
Time frame: within 10-15 days postpartum
Poor Milk Perception Scale (PMPS): A minimum of 0 and a maximum of 50 points can be obtained from the scale. The higher the total score obtained, the higher the perception of milk adequacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Yes. It is planned to publish the obtained data.
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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.
Hava Özkan, Özkan principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing Thera Pearl in people with Breast Feeding, run by Amasya University.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact betül uzun, özer (539 670 29 42 ext. +90, betul123uzun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol Breastfeeding Assessment Tool (BBAT): (time frame: within 24 hours of postpartum). The study lists 9 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 19 Jul 2023.