NCT05869019

Brief Summary

The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices. This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale. For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items. For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group. Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Status
unknown

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

April 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

April 10, 2023

Last Update Submit

September 1, 2023

Conditions

Keywords

prematüremotherscale

Outcome Measures

Primary Outcomes (1)

  • Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.

    Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care

    On the first day of the babies' discharge, face-to-face interviews will be provided with mothers.

Secondary Outcomes (1)

  • Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.

    Face-to-face interviews will be provided with mothers 15 days after their babies are discharged from the premature intensive care unit.

Study Arms (1)

providing education

EXPERIMENTAL

There are two groups, training and non-training.

Other: education

Interventions

Premature baby care training will be provided.

providing education

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will be conducted with mothers of premature babies.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged),
  • Continuing prematurity of the baby according to the corrected age,
  • Full-time care of the baby at home by the mother,
  • Mothers can speak and understand Turkish,
  • Voluntary written and verbal informed consent was obtained from the mothers.

You may not qualify if:

  • Being a term baby
  • The mother has an ongoing psychological diagnosis,
  • The mothers' unwillingness to continue working at any stage of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

April 10, 2023

First Posted

May 22, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share