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

4. Dezember 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

113

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Truthahn
      • Kutahya, Truthahn, 43000
        • Kutahya Health Science University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental Group
The mothers in the experimental group (60) were administered.
Verhalten: 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.
Kein Eingriff: Control Group
The mothers in the control group (60) were given the routine care.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pre- Test Severity of Physical Symptoms
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-Test Severity of Physical Symptoms
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aysegul Durmaz

Ermittler

  • Hauptermittler: Aysegul Durmaz, KSBU

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Februar 2019

Primärer Abschluss (Tatsächlich)

1. Juli 2019

Studienabschluss (Tatsächlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

29. November 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Dezember 2020

Zuerst gepostet (Tatsächlich)

7. Dezember 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Dezember 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Dezember 2020

Zuletzt verifiziert

1. Dezember 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Personalized Phy. Symp. Disc.

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

all IPD that underlie results in a publication

IPD-Sharing-Zeitrahmen

Starting 6 months after publication

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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