NCT04783324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

January 22, 2021

Last Update Submit

October 28, 2021

Conditions

Keywords

Mobile ApplicationsPostpartum PeriodAdaptationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: E-Mobile Health Application

Control Group

NO INTERVENTION

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

Interventions

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

Experimental Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Koru Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozkan Sat S, Yaman Sozbir S. Randomized Controlled Trial of a Mobile Health Application Based on Roy's Adaptation Model on Postpartum Adaptation. Nurs Res. 2023 May-Jun 01;72(3):E16-E24. doi: 10.1097/NNR.0000000000000647. Epub 2023 Feb 21.

Study Officials

  • Şengül Yaman Sözbir, PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study consists of two groups: Experimental group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

March 5, 2021

Study Start

March 25, 2021

Primary Completion

August 29, 2021

Study Completion

August 29, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations