Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit

NCT ID: NCT06125548

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2023-01-10

Brief Summary

Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.

Detailed Description

Support of prolactin and oxytocin hormones is needed for adequate production and secretion of breast milk. Many factors affect the levels of oxytocin and prolactin in the blood, such as the health status of the mother and the baby after birth, their separation for a while, nutrition, light, stress, fear, and lack of social support. Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.

Conditions

Amount of Breast Milk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Lactation Management Model-Experimental

The women in the experimental group were told about the care technique in accordance with the Lactation Management Model and were asked to apply it regularly for 3 days.The content of the Lactation Management Model includes skin-to-skin contact, hot application to the breast, relaxation and breast massage, and process monitoring.In this regard, the mother should apply skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes manual milking, 2 minutes . nipple stimulation, stroking for 3 minutes).

Group Type: EXPERIMENTAL

Lactation Management Model

Intervention Type: OTHER

The mother provides skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes by hand milking, 2 minutes by breast massage). Head stimulation, stroking for 3 minutes) were asked.

Non-application group- Control

No treatment was performed on women in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lactation Management Model

The mother provides skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes by hand milking, 2 minutes by breast massage). Head stimulation, stroking for 3 minutes) were asked.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-35,
• The baby is still in intensive care,
• Gave birth at 34 weeks of gestation and above,
• The baby was taken to intensive care within the first 3 days after birth,
• The baby will stay in the neonatal intensive care unit for at least 3 more days,
• The baby has started breastfeeding,
• Giving breast milk to the baby by expressing it,
• Not using any medication that will affect milk quantity,
• Does not have a psychiatric disease that will affect breastfeeding in the postpartum period,
• Availability by phone, language, etc. Mothers who do not have communication problems.

Exclusion Criteria

• Not between the ages of 18-35,
• The baby is discharged from intensive care,
• Those whose gestational age is less than 34 weeks,
• The baby is taken to intensive care after the first 3 days after birth,
• The baby is in the neonatal intensive care unit for at least 3 days,
• The baby has not started breastfeeding,
• Breastfeeding,
• Those who use medication that will affect the amount of milk,
• Having a psychiatric disease that will affect breastfeeding in the postpartum period,
• Mothers with communication problems.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Aslı EKER

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Mersin University Midwifery

Identifier Type: -

Identifier Source: org_study_id