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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnant Women; Mobile Applications; Adaptation; Postpartum Period
• Intervention / Treatment: Behavioral: E-Mobile Health Application

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Koru Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Şengül Yaman Sözbir, PhD, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): August 29, 2021

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Adaptation; Mobile Applications; Postpartum Period
• Other Study ID Numbers: SultanOzkan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No