Development of Postnatal Mobile Support Application
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|ClinicalTrials.gov Identifier: NCT03415321|
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression Postnatal Complication Nurse's Role||Device: Postpartum Mobile Support Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|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 of Mothers' Anxiety and Postpartum Depression Symptoms: Pre-Test Post-Test Randomized Controlled Study|
|Actual Study Start Date :||April 4, 2019|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||February 20, 2020|
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
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03415321
|Necmettin Erbakan University|
|Konya, Turkey, Konya|
|Principal Investigator:||Vesile KOÇAK||Researcher|