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

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status: Active, not recruiting

Conditions: Breast Cancer; Lymphedema; Breast Surgery

Treatments: Other: First with the traditional tape measure , then with the arm circumference measurement tool; Other: First with the arm circumference measurement tool, then with the traditional tape measure

Study type: Interventional

Funder types: Other

Identifiers

NCT07154771

2025-347

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 4 patient groups

İntervention-control group (Patient)

Other group

Description:

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.

Treatment:

Other: First with the arm circumference measurement tool, then with the traditional tape measure

Control-Intervention Group (Patients)

Other group

Description:

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.

Treatment:

Other: First with the traditional tape measure , then with the arm circumference measurement tool

Intervention-Control Group (Nurses)

Other group

Description:

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.

Treatment:

Other: First with the arm circumference measurement tool, then with the traditional tape measure

Control-Intervention Group (Nurses)

Other group

Description:

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.

Treatment:

Other: First with the traditional tape measure , then with the arm circumference measurement tool