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Completed

NCT Number: NCT04741672

Home Support for Mothers Whose Premature Infants

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mothers

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Providing guidance after discharge routine procedure and calling one week after discharge.

Behavioral

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.

Discharge routine procedure.

Behavioral

Discharge routine procedure.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2021
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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