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

NCT05806892 | Unknown

• 1 other identifier: AmasyaU-betuluzun-002
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Feeding

Keywords

postpartum period; Thera Pearl; Breastfeeding Self-Efficacy; randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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.

Other: Thera Pearl

Control

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Thera Pearl OTHER

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.

Experiment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Amasya University: lead
• Ataturk University: collaborator

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Hava Özkan, Özkan

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

betül uzun, özer

CONTACT

539 670 29 42; betul123uzun@gmail.com

Özlem arı, arı

CONTACT

507 640 25 12; slymnkyr.25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is aimed to blind the puerperant women participating in the research.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 10, 2023
• Study Start: July 24, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 15, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It is planned that the data obtained will be published within 4 months.
• Access Criteria: The article published in a journal suitable for the research topic can be read by the members of the journal.