Training of Arms to Reduce Pain With Peripheral Venous Catheter

Pain Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05716217
• Other study ID #: Vein-project
• Status: Terminated
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: April 16, 2024

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pain
• Veins

Intervention

Other:
• Arm training
Daily arm training program

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle	Southern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Vein status	Number of useable veins (assessed via ultrasound)	Measured at baseline
Secondary	Vein status	Number of useable veins (assessed via ultrasound)	Measured after five weeks of training/controll
Secondary	Vein status	Number of useable veins (assessed via ultrasound)	Measured after eight weeks of training/control