Development and Usability Evaluation of an Arm Circumference Measurement Tool For Patients Undergoing Breast Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

First with the arm circumference measurement tool, then with the traditional tape measure: Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the newly developed arm circumference measurement device, followed by the traditional tape measure.

First with the traditional tape measure , then with the arm circumference measurement tool: Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the traditional tape measure, and then using the newly developed arm circumference measurement device.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Intra-rater Reliability — 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 — 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.

Trial sites (1)

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