The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit

NCT06741176 | Active Not Recruiting DMC

• 1 other identifier: NEU2024breastmilk
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn babies may need to stay in neonatal intensive care units (NICU) immediately after birth for many reasons such as premature birth, low birth weight, respiratory distress, infection, jaundice. Depending on the cause and level of the newborn's illness, the length of stay may be extended, lasting weeks or even months. This situation negatively affects mother-infant bonding, causing mothers to be unable to establish healthy communication with their babies. For mothers in particular, leaving their babies in the NICU makes them feel inadequate and hopeless. Attachment is the emotional bond that a baby establishes with its mother or the person who cares for it. This bond established between the mother and the baby affects the emotional, social, cognitive and moral development of the individual throughout their life. It is known that secure attachment contributes to the physical and mental development of babies, while insecure attachment is associated with various mental illnesses. For these reasons, it is important to initiate secure attachment between the mother and the baby during the neonatal period. The aim of this planned study is to examine the effect of the messages left by mothers whose babies are in the NICU on mother-infant bonding and the mothers' level of hope. Mothers leaving messages for their babies provides a context in which they can express themselves to their babies and may positively affect mother-infant bonding and the mother's level of hope in the NICU.

Conditions

Breast Milk; Premature

Keywords

Premature; breast milk; Mother; attachment; Hope

Outcome Measures

Primary Outcomes (3)

• Sociodemographic Information Form

  The form, which was developed by the researcher by scanning the literature, has a total of 16 questions. It includes questions such as the mother's age, occupation, education level, baby's gender, weight, and week of birth.

  It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)

• Mother-Infant Bonding Scale

  The eight-item scale filled out by the mother consists of eight items that include the emotional states the mother feels towards her baby after birth. The scale items consist of a four-point Likert-type rating, from "(0) very much" to "(3) never". Five items indicating negative emotions are scored in reverse (3-0). A high score indicates that the mother and baby have a bonding problem. The internal consistency coefficient of the scale was reported as 0.66 in the validity and reliability study.

  Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)

• State Hope Scale

  The Turkish validity and reliability study of the State Hope Scale developed by Snyder et al. (1996) was conducted by Bekmezci et al. (2021). The statements in the Hope Scale were measured with an eight-point Likert (1=Absolutely false, 8=Absolutely true). The State Hope Scale consists of 2 dimensions: active thought and the ability to think of alternative ways to reach the goal. Questions 1, 3 and 5 in the scale measure the ability to think of alternative ways to reach the goal; questions 2, 4 and 6 measure the active thought dimension. High scores from the dimensions indicate high hope.

  Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)

Study Arms (2)

Experimental

EXPERIMENTAL

Breast Milk

Behavioral: Experimental

Control

ACTIVE COMPARATOR

Control

Behavioral: Control

Interventions

Experimental BEHAVIORAL

The research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The mothers in the experimental group will be asked to write messages to their babies on the milk bags they bring in the mornings for 3 days. They will be asked to write on the paper attached to the milk bag what they want to tell their baby that the investigators will read the message to them and to return it every morning. The post-test of all surveys will be conducted at the end of the 3rd day.

Experimental

Control BEHAVIORAL

The research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The post-tests will be conducted 3 days after the pre-test without any messages being requested from the mothers in the control group.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the care of the baby,
• Reading and understanding Turkish,

You may not qualify if:

• \- No psychological problems in the mother

Sponsors & Collaborators

• Semra Kose: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor (PhD, RN)

Model Details: It is a randomized controlled trial in experimental design.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: August 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)