Development and Usability Evaluation of an Arm Circumference Measurement Tool For Patients Undergoing Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Intra-rater Reliability
研究概览
简要总结
The aim of this study is to develop an arm circumference measurement device that can be used by both patients and nurses in the follow-up of upper extremity lymphedema, which may occur as a result of breast cancer surgery, and to evaluate its usability. This study also seeks to determine whether the developed device can offer a more accurate, faster, and more practical alternative compared to traditional tape measurements. The main questions it aims to answer are:
Is there a significant difference in intra-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure?
Is there a significant difference in inter-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure?
Is there a significant difference in the measurement results obtained by nurses and patients when using the arm circumference measurement device compared to a traditional tape measure?
Do nurses and patients experience a difference in the duration of arm circumference measurements when using the measurement device versus a traditional tape measure?
Is there a difference in the satisfaction levels of nurses and patients regarding arm circumference measurements performed with the measurement device versus a traditional tape measure? This study will be conducted in two phases: the first phase involves the development of the arm circumference measurement tool, and the second phase involves the evaluation of its usability through a double-blind, two-group, crossover randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the participants (patients and nurses) and the statistician conducting the data analyses are blinded to the group assignments of the participants
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently working in General Surgery or Surgical Oncology clinics
- •Aged 18 years or older
- •Newly diagnosed with breast cancer confirmed by histopathology
- •Planned to undergo radical mastectomy, modified radical mastectomy, or breast-conserving surgery
- •Scheduled for axillary lymph node dissection (at least two lymph nodes to be dissected)
- •Able to understand information related to circumference measurement and perform the required skills
排除标准
- •Patients who have undergone bilateral lymph node dissection
- •Patients with a prior diagnosis and treatment for breast cancer (surgery, chemotherapy, etc.)
研究组 & 干预措施
İntervention-control group (Patient)
The intervention-control group will first perform circumference measurements using the arm circumference measurement device, followed by measurements with the tape measure. The measurement values obtained by the patients will be recorded in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration of the measurements, which will also be documented in the form.
干预措施: First with the arm circumference measurement tool, then with the traditional tape measure (Other)
Control-Intervention Group (Patients)
The control-intervention group will first perform circumference measurements using the tape measure, followed by measurements with the arm circumference measurement device. The measurement values obtained by the patients will be recorded in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration of the measurements, which will also be documented in the form.
At the end of the procedure, all patients will complete the Visual Analog Scale (VAS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and Patient Interview Form.
干预措施: First with the traditional tape measure , then with the arm circumference measurement tool (Other)
Intervention-Control Group (Nurses)
The intervention-control group will first perform circumference measurements using the arm circumference measurement device, followed by measurements with the tape measure. Nurses will record their measurement values in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration, which will also be noted in the form.
干预措施: First with the arm circumference measurement tool, then with the traditional tape measure (Other)
Control-Intervention Group (Nurses)
The control-intervention group will first perform circumference measurements using the tape measure, followed by measurements with the arm circumference measurement device. Nurses will record their measurement values in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration, which will also be noted in the form.
At the end of the procedure, all nurses will complete the Visual Analog Scale (VAS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and Nurse Interview Form.
干预措施: First with the traditional tape measure , then with the arm circumference measurement tool (Other)
结局指标
主要结局
Intra-rater Reliability
时间窗: Preoperative period (Same day, within 30 minutes between repeated measurements.) The same rater (nurse/patient/researcher) performs repeated measurements on the same arm with both methods within a short interval to assess consistency.
The consistency of repeated measurements performed by the same individual (nurse, patient, or researcher) using different methods (tape measure and the newly developed arm circumference measurement device). Evaluated separately for the right and left arms. Comparisons will be made between the two measurement methods.
Inter-rater Reliability
时间窗: Preoperative period (Same day, sequential measurements within 1 hour by different raters.) Measurements by different raters (nurse, patient, researcher) are conducted on the same day in a fixed sequence.
The agreement between different raters (nurse-patient, nurse-researcher, patient-researcher) using the same method (either tape measure or the new measurement device). Evaluated for both arms and both measurement tools. Inter-rater agreement will be assessed across all rater combinations.
次要结局
- Measurement Duration(Preoperative period (all measurements for both arms; each method's duration recorded separately and immediately))
- User Satisfaction - Visual Analog Scale (VAS)(Preoperative period (each participant completes both measurement methods; immediately after finishing all measurements for both arms, the participant completes the same-day questionnaire without delay))
- User Satisfaction - Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)(Preoperative period (questionnaire completed immediately after all measurements on both arms using both methods))
- Open-ended Feedback (Interview Forms)(Preoperative period (open-ended feedback collected immediately after completing both measurement methods and satisfaction scales during the same session) Türkçe:)
研究者
Rumeysa Ozcelik
Research Assistant
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi