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The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth

2021년 5월 30일 업데이트: Prof. Mordechai Dulitzky, Sheba Medical Center
The woman's body undergoes many physiological changes during pregnancy, which can cause muscle weakness and postpartum joint instability. In addition, the intensive care of the baby sometimes involves extreme body postures and mechanical loading on the hands, which are considered as ergonomic risk factors. Therefore, postpartum women may be particularly vulnerable to musculoskeletal disorders (MSDs). As far as we know, there is no evidence-based intervention on this issue.

연구 개요

상세 설명

The study will be conducted in the Obstetrics Departments at the Sheba Medical Center. After approval by the Helsinki Committee at the Medical Center all subjects who meet the inclusion criteria will be asked to sign an informed consent form for participation in the study.

The first data collection point will be in the early days after birth, when the subjects are still hospitalized. All the subjects will fill out a demographic questionnaire and two more questionnaires regarding the prevalence and intensity of MSD. The REBA, a standardized observation will be conducted to identify the level of ergonomic risk during the performance of two tasks of baby care .

The REBA will be analyzed by a therapist who is blinded to the participants group belonging.

The participants will be assigned into two groups, intervention group and control group. Number of birth and participant age will be adjusted between the groups. The intervention group will participate in a workshop regarding ergonomic principles in baby care. A brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, participants in the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message, along with a request to report the intensity of pain. The control group will not receive the intervention at this time but will also be asked to fill in the scale at the same time points.

Three months after delivery, all subjects will complete the questionnaires regarding the prevalence and intensity of MSD. The REBA will be performed in order to identify the ergonomic risk level during the performance of the same two tasks of baby care. At this point, the control group will receive the intervention in the format of the brochure and videos sent via email or WhatsApp.

The final data collection will be six to twelve months after delivery when all subjects will complete the same questionnaires and a recurrent REBA standardized observation in order to identify the ergonomic risk level during the performance of the same two baby-care tasks will be performed for the last time.

연구 유형

중재적

등록 (실제)

50

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

      • Ramat Gan, 이스라엘, 52621
        • Sheba medical center

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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Women aged 20-40
  • Hospitalized in a maternity ward in a hospital after the birth of one baby
  • Delivery occurred after 37 weeks' gestation

Exclusion Criteria:

  • Women with previous orthopedic or rheumatic problems
  • Women with neuropathic problems due to non-gestational diabetes
  • Women with neurological diseases.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention group
The intervention group will participate in a workshop regarding ergonomic principles in baby care. Finally, a brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message.
Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.
Participant will receive a brochure summarizing the main contents of the workshop.
During the next three months after the beginning of the research, they will receive videos that will be a reminder of the principles learned in the workshop.
간섭 없음: Control group
The control group will not receive any intervention during the data collection period. The intervention will be given three months after the beginning of the research, in the format of the brochure and videos sent via email or WhatsApp.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
기간: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
This outcome measure will be determined by the Rapid Entire Body Assessment (REBA). A posture analyze assessment for evaluating workloads that are at risk for developing musculoskeletal problems. This measure divides the body into 6 areas that are individually encoded and relates to changes in muscle activity that occur due to static, dynamic, unstable, or variable posture (Al Madani & Dababneh, 2016). The final risk score ranges from 1 (minimum) to 15 (maximum) (Ratzon and Schechter-Margalit, 2007), and the final score describes 5 levels of risk that relate to the need for intervention, with 1 meaning "no need for intervention" and 5 means "immediate need for intervention. "(Al Madani & Dababneh, 2016). This assessment tool is commonly used in the field of ergonomics.
We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
The change in the prevalence of musculoskeletal pain
기간: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
This outcome measure will be determined by the Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms (SNQ). The tool is designed for self-filling or for use as an interview (Kuorinka et al., 1987). It is divided into 9 anatomical areas that include the neck, shoulders, elbow, wrist, upper back, lower back, hip, knee and ankle. For each area, there are 3 yes / no questions that relate to the presence of musculoskeletal pain in the last 12 months and 7 days, and to having a functional limitation due to their presence in each area.Ratzon & Mizrachi (2008), added an extension to a questionnaire that included the arm, forearm, palm, and each finger. This supplement was found as valid against the Disabilities of the Arm Shoulder and Hand Questionnaire (DASH) which is moderately correlated with the original SNQ questionnaire (Ratzon & Mizrachi, 2008).
We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
The change in the intensity of musculoskeletal pain
기간: We will measure five outcomes: Pre-intervention(Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1,2,3 and 4: One month, Two months, Three months and Six to Twelve months after the first meeting.
This outcome measure will be determined by the Numeric rating scale (NRS). A tool for measuring the intensity of pain in adults. It is a numerical version of The Visual Analog Scale (VAS). The subject is asked to select a number from 0 to 10 which best reflects the current pain intensity he has felt in the last 24 hours, relative to 13 different anatomical regions. The scale is shown in the horizontal line with the number 0 meaning "not painful" and the number 10 meaning "very painful".
We will measure five outcomes: Pre-intervention(Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1,2,3 and 4: One month, Two months, Three months and Six to Twelve months after the first meeting.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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)

2020년 2월 23일

기본 완료 (실제)

2020년 5월 31일

연구 완료 (예상)

2021년 8월 31일

연구 등록 날짜

최초 제출

2020년 1월 21일

QC 기준을 충족하는 최초 제출

2020년 1월 26일

처음 게시됨 (실제)

2020년 1월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 30일

마지막으로 확인됨

2021년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SHEBA-19-6259-MD-CTIL

개별 참가자 데이터(IPD) 계획

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