- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04244279
The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Ramat Gan, Израиль, 52621
- Sheba Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: 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.
|
Без вмешательства: 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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
Временное ограничение: 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.
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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.
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The change in the prevalence of musculoskeletal pain
Временное ограничение: 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.
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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).
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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
Временное ограничение: 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.
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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".
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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.
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Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SHEBA-19-6259-MD-CTIL
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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