- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05438056
The Effect of the Mobile Application Developed for Home Care of Preterm
June 28, 2022 updated by: Gülçin KORKMAZ YENİCE, Ankara University
The Effect of the Mobile Application Developed for Home Care of the Premature Baby on the Mother's Baby Care Skills, Self-efficacy and Mother-infant Bonding
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy.
A mobile application will be developed to support mothers who care for their premature babies at home after discharge.
The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit.
After the babies are discharged, mothers will be trained at home with a mobile application.
Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
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;
- 32-37 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
Exclusion Criteria:
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: providing training to mothers of premature babies with a mobile application
providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge
|
providing training to mothers of premature babies with a mobile application
|
|
No Intervention: standard education prior to discharge control group; standard education prior to discharge
standard education prior to discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
parent self-efficacy scale
Time Frame: up to 10 months
|
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
Time Frame: up to 14 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maternal attachment scale
Time Frame: up to 10 months
|
scale that measuring mother-infant attachment.
The unabridged name of the scale is maternal attachment scale.
The lowest score obtained from the scale is 26, the highest score is 104.
A high score indicates high maternal attachment.
|
up to 10 months
|
|
maternal attachment scale
Time Frame: up to 14 months
|
scale that measuring mother-infant attachment.
The unabridged name of the scale is maternal attachment scale.
The lowest score obtained from the scale is 26, the highest score is 104.
A high score indicates high maternal attachment.
|
up to 14 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
baby care knowledge and skills form
Time Frame: up to 14 months
|
Form that measuring baby care knowledge and skills.
The unabridged name of the form is baby care knowledge and skills form.
Since the form created by the researcher has not been finalized, the lowest and highest scores to be obtained from the form are not certain.
A high score indicates a high level of knowledge and skill of the mother.
|
up to 14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 16, 2022
Primary Completion (Anticipated)
August 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 24, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
July 1, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraU06GKY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
When the study is completed and published, the score obtained from the parent self-efficacy scale and maternal attachment scale will be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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