CClinicalTrials.gg
Not yet recruitingNCT05806892Updated Jul 19, 2023

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

An interventional study of Thera Pearl in Breast Feeding, sponsored by Amasya University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Amasya University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Breast Feeding

Keywords

  • postpartum period
  • Thera Pearl
  • Breastfeeding Self-Efficacy
  • randomized controlled trial
03

In context

Lead sponsor

Amasya University is the lead sponsor of 78 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • not willing to participate in research
  • have any disease
  • those who are not with the baby
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
35 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    No intervention will be applied to the control group.

Interventions

  • OtherThera 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 24 hours of postpartum

  2. 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.

    Time frame: within 24 hours of postpartum

  3. 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.

    Time frame: within 24 hours of postpartum

  4. 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.

    Time frame: within 2-7 days postpartum

  5. 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.

    Time frame: within 2-7 days postpartum

  6. 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.

    Time frame: within 2-7 days postpartum

  7. 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.

    Time frame: within 10-15 days postpartum

  8. 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.

    Time frame: within 10-15 days postpartum

  9. 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.

    Time frame: within 10-15 days postpartum

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — It is planned to publish the obtained data.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05806892
Lead sponsor
Amasya University
Collaborators
Ataturk University
Responsible party
Sponsor
First posted
Apr 10, 2023
Start date
Jul 24, 2023 (estimated)
Primary completion
Aug 31, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Jul 19, 2023

Study contacts

betül uzun, özer
Contact
betul123uzun@gmail.com
539 670 29 42 ext. +90
Özlem arı, arı
Contact
slymnkyr.25@gmail.com
507 640 25 12 ext. +90
Hava Özkan, Özkan
principal investigator · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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