Training of Arms to Reduce Pain With Peripheral Venous Catheter

NCT ID: NCT05716217

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-04-16

Brief 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.

Conditions

Pain; Cancer; Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training group

Group Type: EXPERIMENTAL

Arm training

Intervention Type: OTHER

Daily arm training program

Normal care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Arm training

Daily arm training program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanne I Jensen, PhD

Role: STUDY_CHAIR

Vejle Hospital

Locations

Vejle Hospital

Vejle, Southern Jutland, Denmark

Countries

Denmark

Other Identifiers

Vein-project

Identifier Type: -

Identifier Source: org_study_id