Can Postpartum Depression Be Prevented With Care
21. mars 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
112
Fase
- Ikke aktuelt
Kontakter og plasseringer
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Studiesteder
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Erzurum, Tyrkia, 25240
- AtaturkU
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Visual Analogue Scale to Evaluate Fatigue Severity Scores
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The Postpartum Support Scale Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2019
Primær fullføring (Faktiske)
1. april 2020
Studiet fullført (Faktiske)
9. mars 2021
Datoer for studieregistrering
Først innsendt
9. mars 2022
Først innsendt som oppfylte QC-kriteriene
21. mars 2022
Først lagt ut (Faktiske)
24. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AtaturkU-GulsenEryilmaz-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
There is not a plan to make IPD available
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Nei
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