Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Determining the Severity of Physical Symptoms Displayed and Their Level of Perceived Readiness for Discharge After Birth

4. prosince 2020 aktualizováno: Aysegul Durmaz

Determining the Severity of Physical Symptoms Displayed by Mothers Receiving Personalized Care and Their Level of Perceived Readiness for Discharge After Birth

H1a: There is a difference between the severity of physical symptoms displayed by puerperal women who received routine and personalized care during the early postpartum period.

H1b: There is a difference between the levels of readiness for discharge among puerperal women who received routine and personalized care during the early postpartum period.

H0a: There is no difference between the severity of physical symptoms displayed by puerperal women who received routine and personalized care during the early postpartum period.

H0b: There is no difference between the levels of readiness for discharge among puerperal women who received routine and personalized care during the early postpartum period.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This single-blind randomized controlled trial was conducted between the February and December of 2019. The study was carried out at tertiary care hospital in Turkey. The population of this study consisted of the puerperal women who performed vaginal birth at the maternity unit of a hospital.

Considering the possibility that participants of the sample might be lost or abandon the study, 120 mothers who met the criteria of inclusion to experimental (E) (n=60) and control (C) (n=60) groups were included and assigned to both groups using the permuted block randomization method.The investigators randomly allocated the participants either to the intervention group (which received the personalized care), or to control group (which received the routine care). The mothers in the experimental group (60) were administered personalized care while those in the control group (60) were given the routine care.

The pre-test procedure was performed when the mothers' statuses were stabilized one hour after the admittance to the maternity service. The post-test procedure was conducted one hour before the discharge. Routine care was provided to the mothers in both groups. Routine care means the standard care service provided to mothers following the birth. The standard postpartum basic care components were determined based on the guides and protocols of the hospital. There are three core components of postpartum care regarding the routine care service.

The data were collected using the ''Personal Information Form'', ''Postpartum Physical Symptom Severity Scale'' and ''Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM)''.

Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (mean, standard deviation, frequency and percentage values) were used to assess the results. Kolmogorov-Smirnov test was used to review the goodness of fit to normal distribution.

Typ studie

Intervenční

Zápis (Aktuální)

113

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Krocan
      • Kutahya, Krocan, 43000
        • Kutahya Health Science University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • To receive personalized care
  • To have vaginal birth
  • To have singleton birth
  • To be within the early postpartum period (the first 24 hours)
  • Not have complications childbirth
  • Not have chronic diseases or mental disorders
  • Older than 18 years
  • To voluntary to participate
  • To know how to read, write and speak in Turkish
  • To stay within this study until the end
  • To fully complete questionnaire
  • To have a newborn with no complications
  • To have a healthy baby

Exclusion Criteria:

  • To receive routine care
  • To received theoretical training,
  • Not have vaginal birth
  • Having multiple birth
  • Not to be within the early postpartum period (the first 24 hours)
  • Having complications childbirth
  • Having chronic diseases or mental disorders
  • Younger than 18 years
  • To refuse to participate
  • Not knowing how to read, write and speak Turkish
  • To leave early this study
  • Not fill the questionnaire
  • Having a newborn with complications
  • Having a baby in need of medical care

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Experimental Group
The mothers in the experimental group (60) were administered.
Behaviorální: Personalized Care
A clinical and standardized workflow was created for both experimental and control groups. This standardized workflow: consisted of services which included the management of basic medications, routine care regarding the postpartum period, newborn care and health education. After the standardized clinic workflow was formed, a personalized care plan was developed for the experimental group. Each care procedure was shared with the participants in the experimental group. Moreover, all potential alternative care plans were presented to the participants.
Žádný zásah: Control Group
The mothers in the control group (60) were given the routine care.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pre- Test Severity of Physical Symptoms
Časové okno: 1 hour after the admittance to the maternity service
Postpartum Physical Symptom Severity Scale; this 4-point Likert scale has 18 items aiming to determine the physical postpartum symptoms. The scale is scored as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The scale assesses the physical symptoms, such as perineum pain, insomnia, constipation, backpain, headache, hemorrhoid, arthralgia, numbness in hands and feet, vaginal discharge and infection, vaginal bleeding, urinary tract infections, dizziness, varicose vein in legs, urinary incontinence, feeling cold abnormally or coldness in hands and feet, and it evaluates the severity of these symptoms. The total scale score varies between 0 and 54. An increase in the score obtained from the scale indicates high severity of physical postpartum symptoms.
1 hour after the admittance to the maternity service
Pre-Test Readiness for Discharge After Birth
Časové okno: 1 hour after the admittance to the maternity service
Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.
1 hour after the admittance to the maternity service

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Post-Test Severity of Physical Symptoms
Časové okno: 1 hour before the discharge
Postpartum Physical Symptom Severity Scale; this 4-point Likert scale has 18 items aiming to determine the physical postpartum symptoms. The scale is scored as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The scale assesses the physical symptoms, such as perineum pain, insomnia, constipation, backpain, headache, hemorrhoid, arthralgia, numbness in hands and feet, vaginal discharge and infection, vaginal bleeding, urinary tract infections, dizziness, varicose vein in legs, urinary incontinence, feeling cold abnormally or coldness in hands and feet, and it evaluates the severity of these symptoms. The total scale score varies between 0 and 54. An increase in the score obtained from the scale indicates high severity of physical postpartum symptoms.
1 hour before the discharge
Post-Test Severity of Physical Symptoms
Časové okno: 1 hour before the discharge
Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.
1 hour before the discharge

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Aysegul Durmaz

Vyšetřovatelé

  • Vrchní vyšetřovatel: Aysegul Durmaz, KSBU

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2019

Primární dokončení (Aktuální)

1. července 2019

Dokončení studie (Aktuální)

1. prosince 2019

Termíny zápisu do studia

První předloženo

29. listopadu 2020

První předloženo, které splnilo kritéria kontroly kvality

4. prosince 2020

První zveřejněno (Aktuální)

7. prosince 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. prosince 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. prosince 2020

Naposledy ověřeno

1. prosince 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Personalized Phy. Symp. Disc.

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

all IPD that underlie results in a publication

Časový rámec sdílení IPD

Starting 6 months after publication

Kritéria přístupu pro sdílení IPD

If study' IPD are used, my article should be cited.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Poprocedurální propuštění

Klinické studie na Personalized Care

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Latvia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit