- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06741176
The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit
The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit to Their Babies on Mother-Baby Attachment and Hope Level: Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
-
Konya, Meram, Turkey
- Necmettin Erbakan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participation in the care of the baby,
- Reading and understanding Turkish,
Exclusion Criteria:
- No psychological problems in the mother
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
|
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.
|
|
Experimental: Experimental
Breast Milk
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic Information Form
Time Frame: It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)
|
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.
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It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)
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Mother-Infant Bonding Scale
Time Frame: 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)
|
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
Time Frame: 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)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU2024breastmilk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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