NCT05438056

Brief Summary

mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

June 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 22, 2022

Last Update Submit

June 28, 2022

Conditions

Keywords

Mothers, premature, mobile application, education, home care

Outcome Measures

Primary Outcomes (2)

  • parent self-efficacy scale

    scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy

    up to 10 months

  • parent self-efficacy scale

    scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy.

    up to 14 months

Secondary Outcomes (2)

  • maternal attachment scale

    up to 10 months

  • maternal attachment scale

    up to 14 months

Other Outcomes (1)

  • baby care knowledge and skills form

    up to 14 months

Study Arms (2)

providing training to mothers of premature babies with a mobile application

EXPERIMENTAL

providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge

Other: education with mobile application

standard education prior to discharge control group; standard education prior to discharge

NO INTERVENTION

standard education prior to discharge

Interventions

providing training to mothers of premature babies with a mobile application

providing training to mothers of premature babies with a mobile application

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For mothers;
  • Being over the age of 18,
  • Having a premature baby
  • At least primary school graduate,
  • Smart mobile app can be installed have a phone,
  • Being able to understand and speak Turkish,
  • Residing in Ankara
  • For babies;
  • weeks of gestation of the baby (middle and borderline premature)
  • Baby in neonatal intensive care unit to stay
  • Not having undergone a surgical operation,
  • Absence of physical anomalies

You may not qualify if:

  • For Mothers;
  • Diagnosed with postpartum depression
  • unwillingness to participate in the study
  • For babies;
  • \- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled interventional research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 29, 2022

Study Start

December 16, 2022

Primary Completion

August 30, 2023

Study Completion

December 30, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

When the study is completed and published, the score obtained from the parent self-efficacy scale and maternal attachment scale will be shared.