Clinical trial NCT04741672: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Mothers
Keywords: Infant
Mothers
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was pretest-posttest design, randomized controlled trial.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Perceived Maternity Self-Efficacy Scale
timeFrame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
measure: State Anxiety Inventory
timeFrame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz Universtiy
name: Arzu Akcan, PhD
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Ezgi Boz, Postgraduate
role: STUDY_CHAIR
References:
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.