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临床试验/NCT07104227
NCT07104227进行中(未招募)不适用

Effects of Body Mechanics Training on Shoulder-back Pain and Breastfeeding Ergonomics for Breastfeeding Mothers

Ege University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
94
试验地点
1
主要终点
Change in Shoulder and Upper Back Pain Intensity in Breastfeeding Mothers Measured by Visual Analog Scale (VAS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: body mechanics training (Behavioral)

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.

干预措施: to inform (Other)

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.

干预措施: to inform (Other)

结局指标

主要结局

Change in Shoulder and Upper Back Pain Intensity in Breastfeeding Mothers Measured by Visual Analog Scale (VAS)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AYSUN EKŞİOĞLU

Associate Professor

Ege University

研究点 (1)

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