Training of Arms to Reduce Pain With Peripheral Venous Catheter

Can Training of the Armsy Reduce Pain When Inserting a Peripheral Venous Catheter, and How is it Experienced That There Can be Challenges With Vein Status for Patients in Cytostatic Treatment?

Female patients undergoing chemotherapy for breast cancer often experience pain and discomfort when a peripheral venous catheter is inserted.

This randomized, controlled trial investigates whether there is a difference in the degree of pain during PVC insertion in patients who exercise their arms, and whether exercise improves vein status.

Participation involves:

• Everyone must have had their peripheral venous catheter (PVC) inserted at least five times in the DROP-IN, which is an outpatient clinic staffed by anesthesia nurses who are specialists in applying PVCs.
• Everyone will three times be asked to answer some questions in the DROP-IN, have their grip strength measured in both hands, and have the course of the veins in their arms clarified.
• The training group must do arm training exercises daily for at least eight weeks (training equipment is provided)
• Ten participants will at the end of the project period be invited to participate in a telephone interview about experiences of vein status during a cancer treatment course.

Study Overview

• Status: Terminated
• Conditions: Pain; Cancer; Veins
• Intervention / Treatment: Other: Arm training

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Southern Jutland
    • Vejle, Southern Jutland, Denmark, 7100
      • Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Planned neoadjuvant or adjuvant chemotherapy via intravenous peripheral venous cannula placed under ultrasound guidance
• PVC insertion is performed in the DROP-IN outpatient clinic, Department of Anesthesiology, Vejle Hospital, at least four times
• The patient has provided written and orally informed consent
• The patient must be cognitively well preserved and able to understand information

Exclusion Criteria:

• Patients who cannot read and understand Danish
• Patients <18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal care
Experimental: Training group	Other: Arm training; Daily arm training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)	Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale	Measured at baseline
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)	Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale	Measured after five weeks of training/control
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)	Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale	Measured after eight weeks of training/control

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein status	Number of useable veins (assessed via ultrasound)	Measured at baseline
Vein status	Number of useable veins (assessed via ultrasound)	Measured after five weeks of training/controll
Vein status	Number of useable veins (assessed via ultrasound)	Measured after eight weeks of training/control

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Hanne I Jensen, PhD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Vein-project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No