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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Physical Suffering, Post Procedural Discharge

Intervention / Treatment
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* Behavioral: Personalized Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The mothers in the experimental group (60) were administered. | Behavioral: Personalized Care<br>* 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.<br>|
| No Intervention: Control Group<br>The mothers in the control group (60) were given the routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- Test Severity of Physical Symptoms | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Test Severity of Physical Symptoms | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized care, Routine care, Postpartum care, Physical symptom, Discharge