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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04783324
Other study ID # SultanOzkan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2021
Est. completion date August 29, 2021

Study information

Verified date October 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.


Description:

This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum Self-Evaluation Questionnaire total mean score of women who use e-mobile health application created according to Roy's Adaptation Model is not different from the total mean score of women in the control group. Research sample will consist of a total of 62 pregnant women, 31 in the experimental group and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 29, 2021
Est. primary completion date August 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Primiparous - Being in the 32nd week of pregnancy and above - Not getting any diagnosis that poses a risk for pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation) - Speaking Turkish - To be at least a primary school graduate - Having a smart phone with Android operating system Exclusion Criteria: - Multiparous - Being under 32 weeks of pregnancy - Getting any diagnosis that poses a risk to pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation) - Not speaking Turkish - Having a smartphone with an operating system other than Android

Study Design


Intervention

Behavioral:
E-Mobile Health Application
The e-mobile health application prepared by the researcher will be used. E-mobile health application include information about postpartum care.

Locations

Country Name City State
Turkey Ankara Koru Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum Adaptation Postpartum adaptation according to Postpartum Self Evaluation Scale. Postpartum self evaluation questionnaire consists of 82 questions in total. The questions are scored between 1 and 4 points. The minimum value that can be obtained from the scale is 82, the maximum value is 328. It is seen that the lower the score in this scale, the higher the postpartum adaptaion of the individual. At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)
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