- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Erzurum, Kalkon, 25240
- AtaturkU
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Face-to-face training and training booklets were provided in home visits.
As of the fourth home visit, Pilates exercises were performed.
|
|
Inget ingripande: The control group
In the control group women received routine postpartum care.
No interventions were conducted other than routine postpartum care.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Visual Analogue Scale to Evaluate Fatigue Severity Scores
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Postpartum Support Scale Scores
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AtaturkU-GulsenEryilmaz-001
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