Can Postpartum Depression Be Prevented With Care
21 maart 2022 bijgewerkt door: Gulsen Eryilmaz, Ataturk University
Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study
This study was designed to eliminate postpartum insomnia and fatigue and reduce the risk of postpartum depression through the maintenance of structural, personal, and social integrity with holistic care under the guidance of Levine's conservation model for primiparous puerperal women who experience fatigue and are at risk of developing depression.
: A single-blind pretest-posttest randomized controlled study.
Women were called to the hospital on the 7th postpartum day and randomly assigned by a computer program to either the intervention group (n=56) or the control group (n=56).
Participants did not know which group they were in.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
A nursing care program was prepared for the intervention group under the guidance of Levine's conservation model. This program was applied with 7 home visits between the 8th and 80th postpartum days. Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed. The women in the control group received routine care. Pretest and posttest data were collected with a personal data sheet, visual analogue scale for fatigue, Postpartum Physical Symptom Severity Scale, Postpartum Sleep Quality Scale, Edinburgh Postpartum Depression Scale, and Postpartum Support Scale.
Sleep quality improved for the primiparous puerperal women of the intervention group. They had reduced postpartum fatigue and increased energy; maintained their structural, personal, and social integrity; and had decreased risk of developing postpartum depression with the holistic care provided (all p<0.001). A negative correlation was detected between the support subscale posttest total score from the Postpartum Support Scale and the posttest scores of the Edinburgh Postpartum Depression Scale for the women of the intervention group (r=-0.303; p<0.05)
Studietype
Ingrijpend
Inschrijving (Werkelijk)
112
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Erzurum, Kalkoen, 25240
- AtaturkU
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 35 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- primiparous;
- reading and understanding Turkish;
- normal term delivery;
- no risky situations during pregnancy or delivery;
- high score (≥65 points) from the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F),
- score of ≥12 points from the Edinburgh Postpartum Depression Scale (EPDS);
- episiotomy;
- hemoglobin value of at least 10.0 mg/dL;
- no current or past history of psychiatric illness.
Exclusion Criteria:
- inability to communicate
- unwillingness to participate in the research.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: The intervention group
To reduce postpartum depression among the primiparous puerperal women in the intervention group, and a nursing care program was implemented under the guidance of Levine's model.
This program was applied with 7 home visits between the 8th and 80th postpartum days.
Face-to-face training and training booklets were provided in home visits.
As of the fourth home visit, Pilates exercises were performed.
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Face-to-face training and training booklets were provided in home visits.
As of the fourth home visit, Pilates exercises were performed.
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Geen tussenkomst: The control group
In the control group women received routine postpartum care.
No interventions were conducted other than routine postpartum care.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Visual Analogue Scale to Evaluate Fatigue Severity Scores
Tijdsspanne: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
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The highest score that can be obtained for the fatigue subdimension is 130 and the lowest score is 0. The highest score that can be obtained from the energy subdimension is 50 and the lowest score is 0. Higher scores on items measuring fatigue and lower scores on items measuring energy indicate that the severity of fatigue is high.
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1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
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Edinburgh Postpartum Depression Scale Scores
Tijdsspanne: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
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The highest score that can be obtained from the scale is 30.
A score of 12 or more indicates that the individual is at risk of depression.
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1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Postpartum Support Scale Scores
Tijdsspanne: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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The lowest score that can be obtained from the scale is 0 and the highest score is 238.
The higher the total score, the greater the need for support and the greater the support that needs to be received.
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1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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the Postpartum Sleep Quality Scale Scores
Tijdsspanne: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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The lowest and highest possible scores are respectively 0 and 56.
Higher scores indicate lower sleep quality.
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1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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The Postpartum Physical Symptom Severity Scale Scores
Tijdsspanne: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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Total possible scores range between 0 and 54.
Higher scores obtained from this scale indicate higher severity of postpartum physical symptoms.
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1- postpartum 8th day Time Frame: 2- Postpartum 12th week
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2019
Primaire voltooiing (Werkelijk)
1 april 2020
Studie voltooiing (Werkelijk)
9 maart 2021
Studieregistratiedata
Eerst ingediend
9 maart 2022
Eerst ingediend dat voldeed aan de QC-criteria
21 maart 2022
Eerst geplaatst (Werkelijk)
24 maart 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
21 maart 2022
Laatst geverifieerd
1 maart 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AtaturkU-GulsenEryilmaz-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
There is not a plan to make IPD available
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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