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Home Support for Mothers Whose Premature Infants

Primary Purpose

Infant, Premature, Diseases, Mothers

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Providing guidance after discharge routine procedure and calling one week after discharge.
Discharge routine procedure.
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature, Diseases focused on measuring Infant, Mothers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention group

Control group

Arm Description

Providing guidance and calling after discharge routine procedure.

Discharge routine procedure.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2021
Last Updated
July 19, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04741672
Brief Title
Home Support for Mothers Whose Premature Infants
Official Title
Home Support for Mothers Whose Premature Infants Discharged From the Neonatal Intensive Care Unit: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Mothers
Keywords
Infant, Mothers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was pretest-posttest design, randomized controlled trial.
Masking
Participant
Masking Description
The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Providing guidance and calling after discharge routine procedure.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Discharge routine procedure.
Intervention Type
Behavioral
Intervention Name(s)
Providing guidance after discharge routine procedure and calling one week after discharge.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Discharge routine procedure.
Intervention Description
Discharge routine procedure.
Primary Outcome Measure Information:
Title
Perceived Maternity Self-Efficacy Scale
Description
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.
Time Frame
0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
Title
State Anxiety Inventory
Description
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.
Time Frame
0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Akcan, PhD
Organizational Affiliation
Akdeniz Universtiy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ezgi Boz, Postgraduate
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31684903
Citation
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.
Results Reference
background

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Home Support for Mothers Whose Premature Infants

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