NCT07104227

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

July 24, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

breastfeedingergonomicsmusculoskeletal pain

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 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.

Behavioral: body mechanics trainingOther: 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.

Other: to inform

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.

control groupintervention group

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

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsShe must be a woman because she has given birth and is breastfeeding.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Ege University

Izmir, İzmir, 35400, Turkey (Türkiye)

Location

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

Back PainBreast FeedingMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehaviorMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • AYSUN EKŞİOĞLU, Associate Professor

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
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

Locations