Training of Arms to Reduce Pain With Peripheral Venous Catheter

• Sponsor: Vejle Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05716217
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.3
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Cancer; Veins	Other: Arm training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group is randomly assigned to an 8-week daily arm training program. The other group receives normal careOne group is randomly assigned to an 8-week daily arm training program. The other group receives normal care
• Masking: Single (Care Provider)
• Masking Description: The anaesthesia nurses inserting PVCs and registering data are blinded to the participants' study allocation.
• Primary Purpose: Treatment
• 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?
• Anticipated Study Start Date: Feb 20, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain) [Measured at baseline]

   Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale

2. Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain) [Measured after five weeks of training/control]

   Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale

3. Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain) [Measured after eight weeks of training/control]

   Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale

Secondary Outcome Measures

1. Vein status [Measured at baseline]

   Number of useable veins (assessed via ultrasound)

2. Vein status [Measured after five weeks of training/controll]

   Number of useable veins (assessed via ultrasound)

3. Vein status [Measured after eight weeks of training/control]

   Number of useable veins (assessed via ultrasound)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vejle Hospital	Vejle	Southern Jutland	Denmark	7100

Sponsors and Collaborators

• Vejle Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT05716217
• Other Study ID Numbers: Vein-project
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 8, 2023