Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05806892
Study type Interventional
Source Amasya University
Contact betül uzun, özer
Phone 539 670 29 42
Email betul123uzun@gmail.com
Status Not yet recruiting
Phase N/A
Start date July 24, 2023
Completion date September 15, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04487418 - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Enrolling by invitation NCT02687685 - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH) N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT03033459 - Prenatal Lactation-Focused Motivational Interviewing N/A
Completed NCT02913638 - A Post Breastfeeding Follow-Up Study N/A
Not yet recruiting NCT05846828 - Cognitive Functions in Breastfed Preschool Children
Completed NCT05944471 - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk N/A
Completed NCT05629403 - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05560750 - Lingual Frenulum in Newborn Infants (LINNE) N/A
Completed NCT03232762 - Effects of Diet on Pregnancy Outcome and Child Obesity N/A
Recruiting NCT02186613 - Telephone Support From Primary Care for Breastfeeding Mothers N/A
Completed NCT01687634 - Home Visiting for Low Income, Pregnant Women N/A
Completed NCT01459991 - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women N/A
Completed NCT03574766 - Meditation for NICU Moms N/A
Recruiting NCT03945474 - Osteopathic Manipulation in Breastfed Newborns N/A
Recruiting NCT06107933 - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT04578925 - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents N/A