Training of Arms to Reduce Pain With Peripheral Venous Catheter

NCT05716217 | Terminated

• 1 other identifier: Vein-project
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Vein status

  Measured at baseline

• Vein status

  Measured after five weeks of training/controll

• Vein status

  Measured after eight weeks of training/control

Study Arms (2)

Training group

EXPERIMENTAL

Other: Arm training

Normal care

NO INTERVENTION

Interventions

Arm training OTHER

Daily arm training program

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, Southern Jutland, 7100, Denmark

Location

MeSH Terms

Conditions

Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanne I Jensen, PhD

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The anaesthesia nurses inserting PVCs and registering data are blinded to the participants' study allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group is randomly assigned to an 8-week daily arm training program. The other group receives normal care

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 8, 2023
• Study Start: February 28, 2023
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)