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

NCT ID: NCT04244279

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-23

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Disorders Musculoskeletal Pain Post Partum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
All the he REBA assessment will be analyzed by a therapist who is blinded to the participants group belonging.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Ergonomic workshop

Intervention Type OTHER

Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.

Brochure

Intervention Type OTHER

Participant will receive a brochure summarizing the main contents of the workshop.

Videos

Intervention Type OTHER

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.

Interventions

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Ergonomic workshop

Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.

Intervention Type OTHER

Brochure

Participant will receive a brochure summarizing the main contents of the workshop.

Intervention Type OTHER

Videos

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Mordechai Dulitzky

Head of obstetrics at Sheba Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-19-6259-MD-CTIL

Identifier Type: -

Identifier Source: org_study_id

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