Home Support for Mothers Whose Premature Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Mothers
• Intervention / Treatment: Behavioral: Providing guidance after discharge routine procedure and calling one week after discharge.; Behavioral: Discharge routine procedure.

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arzu Akcan, PhD; Phone Number: +905334436659; Email: aarzu@akdeniz.edu.tr

Study Locations

• Turkey
  • Antalya, Turkey
    • Akdeniz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Providing guidance and calling after discharge routine procedure.	Behavioral: Providing guidance after discharge routine procedure and calling one week after discharge.; Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered.; Behavioral: Discharge routine procedure.; Discharge routine procedure.
Experimental: Control group; Discharge routine procedure.	Behavioral: Discharge routine procedure.; Discharge routine procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Maternity Self-Efficacy Scale	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.	0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
State Anxiety Inventory	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.	0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Study Director: Arzu Akcan, PhD, Akdeniz Universtiy; Study Chair: Ezgi Boz, Postgraduate, Akdeniz University

Publications and helpful links

General Publications

• Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Infant; Mothers
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Premature, Diseases; Premature Birth
• Other Study ID Numbers: 19113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No