- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05295069
Can Postpartum Depression Be Prevented With Care
Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study
Przegląd badań
Status
Szczegółowy opis
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)
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Erzurum, Indyk, 25240
- AtaturkU
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Visual Analogue Scale to Evaluate Fatigue Severity Scores
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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The Postpartum Support Scale Scores
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AtaturkU-GulsenEryilmaz-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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