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Development of Postnatal Mobile Support Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03415321
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
Vesile KOÇAK, Necmettin Erbakan University

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Postnatal Complication Nurse's Role Device: Postpartum Mobile Support Application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial with a two-group pre-test and post-test design.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development of Postnatal Mobile Support Application and Evaluation of the Effectiveness: Randomized Controlled Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention group
Postpartum Mobile Support Application
Device: Postpartum Mobile Support Application

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

No Intervention: Control Group
Routine care

Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: Postpartum 6 weeks ]
    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.

Secondary Outcome Measures :
  1. Mothers' Postnatal Sense of Security [ Time Frame: Postpartum 1th day and 7th day ]
    Parents' Postnatal Sense of Security (PPSS) has been developed by Eva K. Persson et. al. (2007). The mother's version of the PPSS instrument consists of 18 items (possible score 18-72.The items are statements on four point Likert-scales to which the parents are asked if they agree or not, (1- strongly disagree and 4 -strongly agree). A higher score denotes a higher sense of security.

  2. State-Trait Anxiety Inventory [ Time Frame: Postpartum 1th day and 6 weeks ]
    State-Trait Anxiety Inventory (STAI) is self-report questionnaire consists of two subscales each containing 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. It has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale. Higher scores indicate greater anxiety. The scores obtained from the scale range theoretically from 20 to 80. Bigger score indicates high anxiety level; small score indicates low anxiety level.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03415321

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Contact: Vesile KOÇAK 05073300997

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Necmettin Erbakan University Recruiting
Konya, Turkey, Konya
Contact: Vesile KOÇAK    5073300997      
Sponsors and Collaborators
Necmettin Erbakan University
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Principal Investigator: Vesile KOÇAK Researcher

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Responsible Party: Vesile KOÇAK, Research Assistant, Necmettin Erbakan University Identifier: NCT03415321     History of Changes
Other Study ID Numbers: NecmettinEU
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vesile KOÇAK, Necmettin Erbakan University:
Postpartum, Sense of Security, Mobile Support Application
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders