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居民姿势生物反馈研究

2026年10月15日 更新者:Wake Forest University Health Sciences

在你毁掉自己之前检查一下自己:一种可穿戴生物反馈设备,可减少外科住院医生处于非直立姿势的时间和与工作相关的肌肉骨骼疼痛

While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.

研究概览

地位

完全的

详细说明

This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.

Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.

研究类型

介入性

注册 (实际的)

13

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Health Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
  • Completing a one-month rotation at the study sites within the general surgery department during the study period

Exclusion Criteria:

  • Clinically diagnosed inflammatory musculoskeletal disorders per self-report
  • History of orthopedic surgery in the last six months per self-report

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Residents

This is a single arm study. All Resident participants will use the posture biofeedback device.

Participants will wear a commercially available posture training device for a two-week tracking period and a two-week training period while performing laparoscopic procedures.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Percentage of Minutes Spent in the Upright Position During Laparoscopic Procedures
大体时间:Tracking Phase (Days 1-14) and Training Phase (Days 15-28)

The cumulative percentage of minutes in the upright position during all laparoscopic procedures in the two-week Training Phase minus the cumulative percentage of minutes in the upright position during all laparoscopic procedures in the two-week Tracking Phase.

Tracking Phase (Days 1-14) and Training Phase (Days 15-28)

次要结果测量

结果测量
措施说明
大体时间
Change in Self-reported Musculoskeletal Pain Score
大体时间:Baseline, Post Tracking Phase (Day 14), and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort across 20 body regions. The outcome is the sum of body part symptoms. Scores range from 0 to 80 with higher scores indicating symptoms in more body regions and therefore greater musculoskeletal discomfort (a worse outcome).

Baseline, Post Tracking Phase (Day 14), and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Neck Pain Using the CMDQ Composite Weighted Score
大体时间:Baseline and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Right Shoulder Pain Using the CMDQ Composite Weighted Score
大体时间:Baseline and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Left Wrist Pain Using the CMDQ Composite Weighted Score
大体时间:Baseline and Post Tracking Phase (Day 14)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Tracking Phase (Day 14)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:William Sherrill, MD、Wake Forest University Health Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月26日

初级完成 (实际的)

2025年11月2日

研究完成 (实际的)

2025年11月2日

研究注册日期

首次提交

2024年8月19日

首先提交符合 QC 标准的

2024年8月19日

首次发布 (实际的)

2024年8月21日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2025年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRB00115419

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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