Shoulder Pain Back Pain Postpartum PeriodRCTNCT07104227
Effects of Body Mechanics Training on Shoulder-Back Pain and Breastfeeding Ergonomics in Breastfeeding Mothers
A study testing body mechanics training and to inform in people with Shoulder Pain Back Pain Postpartum Period and Back Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain Back Pain Postpartum Period, Back Pain, Postpartum Period
- What is being tested?
- body mechanics training and to inform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Body Mechanics Training on Shoulder-back Pain and Breastfeeding Ergonomics for Breastfeeding Mothers
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
Read the detailed description
The aim of this study is to investigate the effects of body mechanics training on shoulder-back pain and breastfeeding ergonomics for breastfeeding mothers. The study is a randomized controlled intervention study. The study will be conducted in the postpartum ward of Ege University Medical Faculty Hospital. The required sample size for this study was calculated using a priori power analysis using the G*Power 3.1 program. In the calculation, a minimum of 94 people were calculated as 47 for the intervention group and 47 for the control group for a 95% confidence interval and 80% power. The study will be applied to breastfeeding mothers who have given birth vaginally; women who have given birth by cesarean section will not be included. The initial data will be collected face-to-face. Breastfeeding status and pain levels will be evaluated before the mothers are discharged. It will be stated that the follow-up data of the intervention group will be collected via telephone interview and an interview-monitoring plan will be created together with the mother. The mothers in the intervention group will be called at 6 weeks and 3 months postpartum to evaluate their back and neck pain and breastfeeding ergonomics. The mothers in the control group will be called simultaneously with the intervention group at 6 weeks and 3 months postpartum to evaluate their back and neck pain. "Demographic and Health Data Form", "Breastfeeding Ergonomics Scale", "Visual Analog Scale" for pain assessment, Low Back Pain Function Scale, and neck disability questionnaire form will be used to collect data. After the research data are obtained, the data will be analyzed using SPSS 25.0 (Statistical, Package for. Social Sciences) program. Follow-up findings of the intervention and control groups; Analysis of Variance (ANOVA) and ANCOVA will be applied to measurements with normal distribution in at least three independent group comparisons (within groups), and Kruskal Wallis analysis will be applied to measurements that do not have a normal distribution.
- Being tested
- body mechanics training, to inform
- Keywords
- breastfeeding, ergonomics, musculoskeletal pain
- Medical subject headings
- Back Pain, Breast Feeding, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body mechanics trainingBehavioural
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
to informOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 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 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. Receives: Behavioral: body mechanics training; Other: to inform |
| control group | Sham comparator | The 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. Receives: Other: to inform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks, 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Pain Back Pain Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 to divide 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSUN EKŞİOĞLU, Ege University
- Investigators
- AYSUN EKŞİOĞLU, Associate Professor, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104227
- Sponsor's protocol ID
- SUMEYYE BALCI
- Other IDs
- ege
- Acronym
- RCT
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We think that the study will be interpreted better.
Publications
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.
PubMed 31737269
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Mechanics Training on Shoulder-back Pain and Breastfeeding Ergonomics for Breastfeeding Mothers
- ClinicalTrials.gov ID
- NCT07104227
- Acronym / sponsor ID
- RCT / SUMEYYE BALCI
- Keywords
- breastfeeding, ergonomics, musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim of this study is to investigate the effects of body mechanics training on shoulder-back pain and breastfeeding ergonomics for breastfeeding mothers. The study is a randomized controlled intervention study. The study will be conducted in the postpartum ward of Ege University Medical Faculty Hospital. The required sample size for this study was calculated using a priori power analysis using the G*Power 3.1 program. In the calculation, a minimum of 94 people were calculated as 47 for the intervention group and 47 for the control group for a 95% confidence interval and 80% power. The study will be applied to breastfeeding mothers who have given birth vaginally; women who have given birth by cesarean section will not be included. The initial data will be collected face-to-face. Breastfeeding status and pain levels will be evaluated before the mothers are discharged. It will be stated that the follow-up data of the intervention group will be collected via telephone interview and an interview-monitoring plan will be created together with the mother. The mothers in the intervention group will be called at 6 weeks and 3 months postpartum to evaluate their back and neck pain and breastfeeding ergonomics. The mothers in the control group will be called simultaneously with the intervention group at 6 weeks and 3 months postpartum to evaluate their back and neck pain. "Demographic and Health Data Form", "Breastfeeding Ergonomics Scale", "Visual Analog Scale" for pain assessment, Low Back Pain Function Scale, and neck disability questionnaire form will be used to collect data. After the research data are obtained, the data will be analyzed using SPSS 25.0 (Statistical, Package for. Social Sciences) program. Follow-up findings of the intervention and control groups; Analysis of Variance (ANOVA) and ANCOVA will be applied to measurements with normal distribution in at least three independent group comparisons (within groups), and Kruskal Wallis analysis will be applied to measurements that do not have a normal distribution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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 to divide 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Behavioral: body mechanics training, Other: to informAfter 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 comparator | Other: to informThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body mechanics trainingRandomization: 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 | Behavioural | intervention group |
| to informKontrol 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. | Other | control group, intervention group |
Primary outcome
Change in Shoulder and Upper Back Pain Intensity in Breastfeeding Mothers Measured by Visual Analog Scale (VAS)
Time frame: Baseline (hospital discharge), 6 weeks postpartum, 3 months postpartum
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.
Change in Breastfeeding Ergonomics Score Measured by the Breastfeeding Ergonomics Assessment Scale (BEAS)
Time frame: Baseline, 6 weeks, 3 months postpartum
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 31737269Afshariani 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.
- Individual participant dataSharing planned: Undecided. We think that the study will be interpreted better.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYSUN EKŞİOĞLU, Associate Professor study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body mechanics training and to inform in people with Shoulder Pain Back Pain Postpartum Period and Back Pain, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder and Upper Back Pain Intensity in Breastfeeding Mothers Measured by Visual Analog Scale (VAS) (time frame: Baseline (hospital discharge), 6 weeks postpartum, 3 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.