NCT04741672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

January 25, 2021

Last Update Submit

July 19, 2023

Conditions

Infant, Premature, DiseasesMothers

Keywords

InfantMothers

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

Providing guidance and calling after discharge routine procedure.

Behavioral: Providing guidance after discharge routine procedure and calling one week after discharge.Behavioral: Discharge routine procedure.

Control group

EXPERIMENTAL

Discharge routine procedure.

Behavioral: Discharge routine procedure.

Interventions

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.

Intervention group
Discharge routine procedure.BEHAVIORAL

Discharge routine procedure.

Control groupIntervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31684903BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Arzu Akcan, PhD

    Akdeniz Universtiy

    STUDY DIRECTOR

  • Ezgi Boz, Postgraduate

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This was pretest-posttest design, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 5, 2021

Study Start

February 22, 2021

Primary Completion

March 1, 2022

Study Completion

August 1, 2022

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)