Effects of Body Mechanics Training on Shoulder-Back Pain and Breastfeeding Ergonomics in Breastfeeding Mothers
RCT
2 other identifiers
interventional
94
1 country
1
Brief Summary
The research will be conducted as a randomized controlled trial and mothers in the intervention group will receive training on posture correction,breastfeeding positions, and shoulder and back muscle strengthening movements. If you agree to participate in this study, you will first be asked to fill out a form regarding your demographic information and health history.Then, the following scales will be applied to evaluate breastfeeding ergonomics, shoulder-back pain, and musculoskeletal system functions:Demographic and Health Data Form, Breastfeeding Ergonomics Scale, Visual Analog Scale (VAS) for Pain Assessment,Low Back Pain Function Scale, and Neck Disability Indicator Questionnaire. Mothers in the intervention group will receive training on body mechanics including posture awareness,breastfeeding positions, and shoulder and back muscle strengthening movements.The training will be conducted in the hospital and at 6 weeks and 3 months after discharge
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 20, 2026
February 1, 2026
4 months
July 24, 2025
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Shoulder and Upper Back Pain Intensity in Breastfeeding Mothers Measured by Visual Analog Scale (VAS)
Pain intensity will be measured using the Visual Analog Scale (VAS) in both the intervention and control groups. VAS is a 10-cm horizontal line where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Scores will be recorded at baseline (hospital discharge), at 6 weeks, and at 3 months postpartum. The primary outcome is the difference in VAS scores between groups over time.
Baseline (hospital discharge), 6 weeks postpartum, 3 months postpartum
Change in Breastfeeding Ergonomics Score Measured by the Breastfeeding Ergonomics Assessment Scale (BEAS)
The Breastfeeding Ergonomics Assessment Scale (BEAS), developed by Ekşioğlu \& Balcı (2024), consists of 14 items with a total score ranging from 14 to 42. Higher scores indicate greater ergonomic risk during breastfeeding. The scale will be administered at baseline (hospital discharge), at 6 weeks, and 3 months postpartum. The outcome is the change in BEAS score over time between the intervention and control groups.
Baseline, 6 weeks, 3 months postpartum
Study Arms (2)
intervention group
ACTIVE COMPARATORAfter the initial data collection, the breastfeeding behaviors of the mothers in the intervention group will be observed. Then, the mothers will be given training on ergonomic breastfeeding, correct breastfeeding positions and body mechanics to strengthen the musculoskeletal system during the breastfeeding process. Then, a booklet showing the content of this training and protective movements will be shared with the mothers. Before the mothers are discharged, their breastfeeding status and pain levels will be assessed. An interview-monitoring plan will be created with the mother, stating that the follow-up data of the intervention group will be collected by telephone interview method. The mothers in the intervention group will be called at 6 weeks and 3 months after birth and their back and neck pain will be assessed.
control group
SHAM COMPARATORThe mothers in the control group will benefit from the information and support services provided by the breastfeeding consultant midwife within the scope of the hospital's routine care services. In addition, a brochure will be prepared for these mothers on the correct posture and breastfeeding positions to be considered during the breastfeeding period and will be given to them. An interview-monitoring plan will be created with the mother, stating that the follow-up data of the control group will be collected by telephone interview method. The mothers in the control group will be called simultaneously with the intervention group at the 6th week and 3rd month after birth to evaluate their back and neck pain.
Interventions
Kontrol grubundaki anneler, hastanenin rutin bakım hizmetleri kapsamında emzirme danışmanı ebe tarafından verilen bilgilendirme ve destek hizmetlerinden yararlanacaklardır. Ayrıca bu anneler için emzirme döneminde doğru duruş ve emzirme pozisyonlarında dikkat edilmesi gereken durumlar konusunda bir broşür hazırlanacak ve kendilerine verilecektir. Kontrol grubunun izlem verilerinin telefon görüşmesi yöntemi ile toplanacağı belirtilerek bir görüşme-izlem planı anne ile birlikte oluşturulacaktır. Kontrol grubundaki anneler müdahale grubu ile eşzamanlı olarak doğum sonu 6. Hafta ve 3.aylarda aranarak sırt ve boyun ağrıları değerlendirilecektir.
Randomization: The "Demographic and Health Data Form" will be applied to the participants by the researcher responsible for randomization, and the information obtained will be kept in consecutively numbered, closed, opaque envelopes. The block randomization method will be used when dividing the participants into intervention and control groups. In order to ensure balance in important demographic and health-related variables, the participants will be randomized by stratifying them according to age. The person responsible for collecting the study data will be unaware of the randomization process until the researcher responsible for randomization reports the results. Intervention group: After the initial data collection, the breastfeeding behaviors of the mothers in the intervention group will be observed. Then, the mothers will be given training on ergonomic breastfeeding, correct breastfeeding positions and body mechanics to strengthen the musculoskeletal system during the breas
Eligibility Criteria
You may qualify if:
- Mother should be 18 years of age or older
- Have given birth vaginally
- Mother should be breastfeeding
- Have good general physical health (no health problems),
- Have no physical disabilities
- Have no chronic disease (no circulatory, respiratory, endocrine, etc.)
- Have not received any physical therapy or manual therapy in the last 6 months
- Have no history of chronic pain related to the musculoskeletal system (fibromyalgia, chronic low back or neck pain, etc.)
- Have a BMI between 18.5 and 24.9
- Have a healthy newborn
- Plan to continue breastfeeding during the study period
- Have no past or current health problems that may affect breastfeeding (breast surgery, use of medications that may affect breastfeeding, etc.)
- The most less than primary level education
You may not qualify if:
- Mothers with any medical history
- Mothers with postural problems (previously diagnosed serious postural disorders such as scoliosis, kyphosis or lordosis)
- Having an orthopedic or neurological disorder diagnosed before or during pregnancy (herniated disc, nerve compression)
- Having had a Caesarean section
- Mothers not wanting to breastfeed
- Mothers not wanting to participate in the study
- Situations where the mother and baby must be separated
- Mothers planning to start a different exercise program during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Ege University
Izmir, İzmir, 35400, Turkey (Türkiye)
Related Publications (1)
Afshariani R, Kiani M, Zamanian Z. The influence of ergonomic breastfeeding training on some health parameters in infants and mothers: a randomized controlled trial. Arch Public Health. 2019 Nov 11;77:47. doi: 10.1186/s13690-019-0373-x. eCollection 2019.
PMID: 31737269BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AYSUN EKŞİOĞLU, Associate Professor
Ege University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2025
First Posted
August 5, 2025
Study Start
August 1, 2025
Primary Completion
December 1, 2025
Study Completion
April 1, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02