Clinical trial NCT04244279: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Disorders
Musculoskeletal Pain
Post Partum
Keywords: De Quervain syndrome
Low back pain
Neck pain
Wrist pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2020-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
timeFrame: 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.
measure: The change in the prevalence of musculoskeletal pain
timeFrame: 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.
measure: The change in the intensity of musculoskeletal pain
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: