The Effect of the E-Mobile Health Application on Postpartum Adaptation

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT04783324

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Period Pregnant Women Adaptation Mobile Applications	Behavioral: E-Mobile Health Application	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study consists of two groups: Experimental group and control group.The study consists of two groups: Experimental group and control group.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effect of the E-Mobile Health Application for Pregnant Women Created Based on the Roy's Adaptation Model on Postpartum Adaptation

Actual Study Start Date :

Mar 25, 2021

Actual Primary Completion Date :

Aug 29, 2021

Actual Study Completion Date :

Aug 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Pregnant women in the intervention group will use the e-mobile health application developed by the researcher.	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.
No Intervention: Control Group Pregnant women in the control group will not be intervened and standard care will be applied.

Arm

Intervention/Treatment

Experimental: Experimental Group

Pregnant women in the intervention group will use the e-mobile health application developed by the researcher.

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.

No Intervention: Control Group

Pregnant women in the control group will not be intervened and standard care will be applied.

Outcome Measures

Primary Outcome Measures

Postpartum Adaptation [At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Koru Hospital	Ankara		Turkey

Sponsors and Collaborators

Gazi University

Investigators

Principal Investigator: Şengül Yaman Sözbir, PhD, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sultan Ozkan, Principal investigator, Gazi University

ClinicalTrials.gov Identifier:

NCT04783324

Other Study ID Numbers:

SultanOzkan

First Posted:

Mar 5, 2021

Last Update Posted:

Nov 5, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sultan Ozkan, Principal investigator, Gazi University

Mobile Applications

Postpartum Period

Adaptation

Randomized Controlled Trial

Study Results

No Results Posted as of Nov 5, 2021