Back to resultsThe Effect of the Mobile Application Developed for Home Care of Preterm
Primary Purpose
Mother, Premature, Education
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
education with mobile application
Sponsored by
About this trial
This is an interventional supportive care trial for Mother focused on measuring Mothers, premature, mobile application, education, home care
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
providing training to mothers of premature babies with a mobile application
standard education prior to discharge control group; standard education prior to discharge
Arm Description
providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge
standard education prior to discharge
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
maternal attachment scale
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.
maternal attachment scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05438056
Brief Title
The Effect of the Mobile Application Developed for Home Care of Preterm
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 16, 2022 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mother, Premature, Education, Home Care, Mobile Application
Keywords
Mothers, premature, mobile application, education, home care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled interventional research
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
providing training to mothers of premature babies with a mobile application
Arm Type
Experimental
Arm Description
providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge
Arm Title
standard education prior to discharge control group; standard education prior to discharge
Arm Type
No Intervention
Arm Description
standard education prior to discharge
Intervention Type
Other
Intervention Name(s)
education with mobile application
Intervention Description
providing training to mothers of premature babies with a mobile application
Primary Outcome Measure Information:
Title
parent self-efficacy scale
Description
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
Time Frame
up to 10 months
Title
parent self-efficacy scale
Description
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.
Time Frame
up to 14 months
Secondary Outcome Measure Information:
Title
maternal attachment scale
Description
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.
Time Frame
up to 10 months
Title
maternal attachment scale
Description
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.
Time Frame
up to 14 months
Other Pre-specified Outcome Measures:
Title
baby care knowledge and skills form
Description
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.
Time Frame
up to 14 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
The Effect of the Mobile Application Developed for Home Care of Preterm
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