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

2020년 12월 4일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

중재적

등록 (실제)

113

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Kutahya, 칠면조, 43000
        • Kütahya Health Science University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Experimental Group
The mothers in the experimental group (60) were administered.
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.
간섭 없음: Control Group
The mothers in the control group (60) were given the routine care.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pre- Test Severity of Physical Symptoms
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Post-Test Severity of Physical Symptoms
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Aysegul Durmaz, KSBU

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 1일

기본 완료 (실제)

2019년 7월 1일

연구 완료 (실제)

2019년 12월 1일

연구 등록 날짜

최초 제출

2020년 11월 29일

QC 기준을 충족하는 최초 제출

2020년 12월 4일

처음 게시됨 (실제)

2020년 12월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 12월 4일

마지막으로 확인됨

2020년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Personalized Phy. Symp. Disc.

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

all IPD that underlie results in a publication

IPD 공유 기간

Starting 6 months after publication

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

절차 후 퇴원에 대한 임상 시험

Personalized Care에 대한 임상 시험

3
구독하다