The Effect of Warm Application to the Breast With the Aid of Thera Pearl on Milk Release and Breastfeeding Success

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Feeding
• Intervention / Treatment: Other: Thera Pearl

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: betül uzun, özer; Phone Number: +90 539 670 29 42; Email: betul123uzun@gmail.com
• Study Contact Backup: Name: Özlem arı, arı; Phone Number: +90 507 640 25 12; Email: slymnkyr.25@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• not willing to participate in research
• have any disease
• those who are not with the baby

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention will be applied to the control group.
Experimental: Experiment; Thera Pearl application will be explained to the woman in detail and the first application will be carried out together in the hospital.	Other: Thera Pearl; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	within 10-15 days postpartum

Collaborators and Investigators

• Sponsor: Amasya University
• Collaborators: Ataturk University
• Investigators: Principal Investigator: Hava Özkan, Özkan, Ataturk University

Study record dates

Study Major Dates

• Study Start (Estimated): July 24, 2023
• Primary Completion (Estimated): August 31, 2023
• Study Completion (Estimated): September 15, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; postpartum period; Breastfeeding Self-Efficacy; Thera Pearl
• Other Study ID Numbers: AmasyaU-betuluzun-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is planned to publish the obtained data.
• IPD Sharing Time Frame: It is planned that the data obtained will be published within 4 months.
• IPD Sharing Access Criteria: The article published in a journal suitable for the research topic can be read by the members of the journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No