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

Not Applicable

Active, not recruiting

• Conditions: Breast Surgery; Breast Cancer; Lymphedema

• Registration Number: NCT07154771
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-10
• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2025-09-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Nurses:

-Currently working in General Surgery or Surgical Oncology clinics

Patients:

• 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

Exclusion Criteria

Patients:

• Patients who have undergone bilateral lymph node dissection
• Patients with a prior diagnosis and treatment for breast cancer (surgery, chemotherapy, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Measurement Duration	Preoperative period (all measurements for both arms; each method's duration recorded separately and immediately)	For each participant (both nurse and patient), the duration of each measurement-performed on both the right and left arms using both the tape measure and the arm circumference measurement device-will be recorded using a stopwatch. These same-day measurements will be used to compare the time efficiency and practicality of the two methods.; Comparison will be made between the two methods in terms of time efficiency and practicality.
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)	Nurses' and patients' satisfaction with each measurement method will be assessed using a Visual Analog Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).; Differences in satisfaction between methods and arms will be analyzed.
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)	Satisfaction with the new measurement device will be evaluated using the standardized QUEST 2.0 questionnaire, which assesses satisfaction with assistive devices and related services.; Higher scores indicate higher levels of satisfaction.; Administered to both nurses and patients.
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:	Qualitative data will be collected through structured interview forms to explore the experiences, perceptions, and suggestions of nurses and patients regarding the use of the new arm circumference measurement device.

Trial Locations

Locations (1)

Gülhane Training and Research Hospital, University of Health Sciences; Ankara, Turkey (Türkiye)