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Clinical Trials/NCT04741672
NCT04741672
Completed
N/A

Home Support for Mothers Whose Premature Infants Discharged From the Neonatal Intensive Care Unit: A Randomized Controlled Study

Akdeniz University1 site in 1 country102 target enrollmentFebruary 22, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
Akdeniz University
Enrollment
102
Locations
1
Primary Endpoint
State Anxiety Inventory
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.

Detailed Description

The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p \<0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
August 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arzu Akcan

Assistant Professor

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • The infant was born prematurely (37 weeks of gestation + 6 days earlier),
  • Does not have advanced congenital anomalies in the baby,
  • Who will carry out the primary care of the infant at home,
  • Reading and writing,
  • Can speak and understand Turkish,
  • Mothers who agreed to participate in the study

Exclusion Criteria

  • Incomplete filling of the forms
  • Mothers who previously had training in newborn care

Outcomes

Primary Outcomes

State Anxiety Inventory

Time Frame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

The scale was developed to measure what has been felt for the last 7 days. It is a Likert-type scale consisting of 20 items and graded between 1 and 4. The scores obtained from the scale range from 20 to 80.

Perceived Maternity Self-Efficacy Scale

Time Frame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

The scale, valid and reliable in our country by Kadiroglu (2018), has 19 items and three sub-dimensions.A minimum of 19 and a maximum of 76 points can be obtained on the scale.

Study Sites (1)

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