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

Primary Purpose

Musculoskeletal Disorders, Musculoskeletal Pain, Post Partum

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ergonomic workshop
Brochure
Videos
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Disorders focused on measuring De Quervain syndrome, Low back pain, Neck pain, Wrist pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
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.
The change in the prevalence of musculoskeletal pain
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).
The change in the intensity of musculoskeletal pain
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".

Secondary Outcome Measures

Full Information

First Posted
January 21, 2020
Last Updated
May 30, 2021
Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT04244279
Brief Title
The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth
Official Title
The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders, Musculoskeletal Pain, Post Partum
Keywords
De Quervain syndrome, Low back pain, Neck pain, Wrist pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A comparative experimental study will be conducted with a sample of 50 postnatal women, divided into two groups: 1. An intervention group that will be sampled in a convenience sample. 2. A control group that will be matched to the intervention group according to maternal age and number of children.
Masking
InvestigatorOutcomes Assessor
Masking Description
All the he REBA assessment will be analyzed by a therapist who is blinded to the participants group belonging.
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ergonomic workshop
Intervention Description
Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.
Intervention Type
Other
Intervention Name(s)
Brochure
Intervention Description
Participant will receive a brochure summarizing the main contents of the workshop.
Intervention Type
Other
Intervention Name(s)
Videos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
Description
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.
Time Frame
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.
Title
The change in the prevalence of musculoskeletal pain
Description
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).
Time Frame
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.
Title
The change in the intensity of musculoskeletal pain
Description
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".
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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