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

Sponsor
Mersin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06125548
Collaborator
(none)
80
1
2
23
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lactation Management Model
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
PROSPECTIVE RANDOMIZED CONTROLLED STUDYPROSPECTIVE RANDOMIZED CONTROLLED STUDY
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
All mothers included in the sample were assigned to experimental and control groups using the randomization table.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Lactation Management Model-Based Care Provided to Mothers With Babies in the Intensive Care Unit on the Amount of Breast Milk and Breastfeeding Duration
Actual Study Start Date :
Jan 9, 2022
Actual Primary Completion Date :
Jul 9, 2022
Anticipated Study Completion Date :
Dec 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Other: 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.

No Intervention: Non-application group- Control

No treatment was performed on women in the control group.

Outcome Measures

Primary Outcome Measures

  1. Scoring system for the amount of breast milk the baby receives [Change from before implementation and 4th week of practice]

    The form developed to evaluate the amount of breast milk the baby receives consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction. Each section is grouped into 3 groups in terms of its features and is evaluated over 0, 1, 2 points. In the evaluation, 10 points mean that breast milk is received in the best way, and 7 points and below mean that breast milk is inadequate.

Secondary Outcome Measures

  1. Breast Milk and Breastfeeding Monitoring Form [Change from before implementation and 4th week of practice]

    It is a form consisting of 5 questions about breastfeeding (2 questions), breast milk (2 questions) and baby's weight (1 question), developed by the researcher in line with the literature.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mersin University Yenisehir Mersin Turkey

Sponsors and Collaborators

  • Mersin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslı EKER, Dr.Lecturer, Mersin University
ClinicalTrials.gov Identifier:
NCT06125548
Other Study ID Numbers:
  • Mersin University Midwifery
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aslı EKER, Dr.Lecturer, Mersin University

Study Results

No Results Posted as of Nov 9, 2023