Clinical trial NCT04656756: Determining the Severity of Physical Symptoms Displayed and Their Level of Perceived Readiness for Discharge After Birth
Official title: Determining the Severity of Physical Symptoms Displayed by Mothers Receiving Personalized Care and Their Level of Perceived Readiness for Discharge After Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Suffering
Post Procedural Discharge
Keywords: Personalized care
Routine care
Postpartum care
Physical symptom
Discharge
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a single blind, prospective, and simple randomized controlled trial. The sample was calculated through Power analysis. Consequently, the sample size calculated for α:0.05 and 1-β= 0.95 was 48.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 size and number of blocks divided into two groups as E and C was calculated as 20 (3E and 3C) with six mothers in each block. Using Microsoft Office Excel 2013, numbers ranging from 1 to 20 were randomly generated.A total of 120 mothers were evenly and homogeneously assigned to both groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre- Test Severity of Physical Symptoms
timeFrame: 1 hour after the admittance to the maternity service
measure: Pre-Test Readiness for Discharge After Birth
timeFrame: 1 hour after the admittance to the maternity service
Secondary outcomes:
measure: Post-Test Severity of Physical Symptoms
timeFrame: 1 hour before the discharge
measure: Post-Test Severity of Physical Symptoms
timeFrame: 1 hour before the discharge
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: KSBU
name: Aysegul Durmaz
role: PRINCIPAL_INVESTIGATOR
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