NCT05806892

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

Status unknown NA Last updated 19 July 2023

What this trial tests

NA trial testing Thera Pearl in Breast Feeding in 35 participants. Status unknown.

Timeline

24 July 2023

Primary endpoint
31 August 2023

15 September 2023

Quick facts

Lead sponsor	Amasya University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	35
Start date	24 July 2023
Primary completion	31 August 2023
Estimated completion	15 September 2023

Drugs / interventions tested

• Thera Pearl

Conditions studied

• Breast Feeding — all drugs for Breast Feeding →

Sponsor

Amasya University

Who can join

Adults 18 to 45, female only, with Breast Feeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Hot Application Applied to the Breast with the Help of the Thera Pearl in the Postpartum Period on Mothers' Milk Perception and Postpartum Breastfeeding Self-Efficacy: A Randomized Controlled Study.
   Ozkan H, Uzun Ozer B, Arı O. · · 2024 · PMID 38786381 · DOI 10.3390/healthcare12100968