Postpartum Sadness Clinical Trial
Official title:
The Effect of Discharge Education on Maternity Blues and Postpartum Depression
NCT number | NCT06293274 |
Other study ID # | sdilek5 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | May 30, 2024 |
The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province. The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | May 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 38-42. Those who gave birth between weeks of gestation, - Those who have had vaginal birth or caesarean section, - Able to speak and understand Turkish, - Those over 18 years of age, - Mothers with a single healthy baby - Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening Exclusion Criteria: - Preterm or postterm birth, - Received psychiatric treatment or used psychotropic medications during pregnancy, - Having a history of substance dependence and/or use in the past 6 months, - Being in the high-risk category, - Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver), - Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography). - Participants who wish to withdraw from the study at any time will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motherhood Sadness Scale | The scale developed to evaluate motherhood blues consists of 32 items and 8 sub-dimensions. These sub-dimensions; skin-to-skin contact, communication, staying in the same room, breastfeeding, physical adaptation, responsibility, culture, economic factors, information and economic support, social support. Scale items contain positive and negative expressions. The scale is graded as 'completely appropriate (5 points), appropriate (4 points), rarely appropriate (3 points), not appropriate (2 points), not at all appropriate (1 point). The minimum score that can be obtained from the scale is 32 and the maximum score is 160. A high total score in the evaluation of the scale indicates experiencing motherhood blues. | 5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days. | |
Primary | Edinburgh Postnatal Depression Scale - EPDS | The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0 and the highest score is 30. Although the cut-off scores for the scale vary between studies, it is stated that a cut-off score of 12 may be sufficient to determine clinical depression. The scale is a screening scale to determine the risk of postpartum depression. | At 6 weeks postpartum, the researcher will call and administer the 10-item Edinburg Postpartum Depression Scale. |
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