Can Postpartum Depression Be Prevented With Care
21. marts 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret 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)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
112
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Erzurum, Kalkun, 25240
- AtaturkU
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: The control group
In the control group women received routine postpartum care.
No interventions were conducted other than routine postpartum care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale to Evaluate Fatigue Severity Scores
Tidsramme: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
|
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.
|
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
|
|
Edinburgh Postpartum Depression Scale Scores
Tidsramme: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
|
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.
|
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Postpartum Support Scale Scores
Tidsramme: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
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.
|
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
|
the Postpartum Sleep Quality Scale Scores
Tidsramme: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
The lowest and highest possible scores are respectively 0 and 56.
Higher scores indicate lower sleep quality.
|
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
|
The Postpartum Physical Symptom Severity Scale Scores
Tidsramme: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
Total possible scores range between 0 and 54.
Higher scores obtained from this scale indicate higher severity of postpartum physical symptoms.
|
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2019
Primær færdiggørelse (Faktiske)
1. april 2020
Studieafslutning (Faktiske)
9. marts 2021
Datoer for studieregistrering
Først indsendt
9. marts 2022
Først indsendt, der opfyldte QC-kriterier
21. marts 2022
Først opslået (Faktiske)
24. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AtaturkU-GulsenEryilmaz-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is not a plan to make IPD available
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .