NCT03415321

Brief Summary

A mobile support application will be developed that will support mothers in the postpartum period and will be tested the effects of application on anxiety and depression symptoms.The study will consist of two phases. The first phase of the action research (participant design method) method will be done to provide postpartum mobile support application. In the second stage, postpartum mobile support application will be evaluated for the anxiety and depression symptoms of the mothers after six weeks of use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

January 8, 2018

Last Update Submit

June 19, 2020

Conditions

Postpartum DepressionPostnatal ComplicationNurse's Role

Keywords

Postpartum, Nurse, Mothers, Anxiety, Depression, Mobile Support

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale

    Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report scale that evaluates depressive symptoms just after delivery developed by Cox et al. (1987). EPDS will be used to assess depression in fathers and mothers. Each item is scored on a four-point scale(0-3), the minimum and maximum scores being 0 and 30,respectively. The prevalence of depression will be identified using the recommended cut-off point of 13 or above. The following severity ranges were established for the EPDS: None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30).The EPDS score should not override clinical judgment. A careful clinical assessment should be carried out to confirm the diagnosis.

    Postpartum 6 weeks

Secondary Outcomes (1)

  • State-Trait Anxiety Inventory

    Postpartum 1th day and 6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Postpartum Mobile Support Application

Device: Postpartum Mobile Support Application

Control Group

NO INTERVENTION

Routine care

Interventions

Postpartum Mobile Support ApplicationDEVICE

Women in the experimental group will use the Postpartum Mobile Support Application during six weeks after birth. Women will be evaluated three times in total, one for the first day after birth, second for the seventh day after birth and the last for the sixth week after birth. Short messages and calls will be remind of women's Postpartum Mobile Support Application use

Intervention group

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Giving birth full term 39 weeks 0 days and 40 weeks 6 days (ACOG 2013)
  • Having a phone with Android feature and having an internet connection
  • Baby's normal birth weight and having APGAR score 8 and above

You may not qualify if:

  • Adolescent pregnants
  • Having anxiety and depression
  • Complication developments in the mother or newborn after delivery
  • Newborn stay in the intensive care unit
  • Visually impaired, hearing impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Konya, Turkey (Türkiye)

Location

Related Publications (1)

  • Kocak V, Ege E, Iyisoy MS. The development of the postpartum mobile support application and the effect of the application on mothers' anxiety and depression symptoms. Arch Psychiatr Nurs. 2021 Oct;35(5):441-449. doi: 10.1016/j.apnu.2021.06.009. Epub 2021 Jun 22.

    PMID: 34561057DERIVED

MeSH Terms

Conditions

Depression, PostpartumAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Vesile KOÇAK

    Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with a two-group pre-test and post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 30, 2018

Study Start

April 4, 2019

Primary Completion

July 30, 2019

Study Completion

February 20, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

TU(1)