NCT07154771

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Surgery
• Breast Cancer
• Lymphedema

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-09-20
• Completion: 2025-11-20
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Turkey (Türkiye)