Clinical trial NCT05716217: Training of Arms to Reduce Pain With Peripheral Venous Catheter
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?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Cancer
Veins
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group is randomly assigned to an 8-week daily arm training program. The other group receives normal care
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
timeFrame: Measured at baseline
measure: Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
timeFrame: Measured after five weeks of training/control
measure: Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
timeFrame: Measured after eight weeks of training/control
Secondary outcomes:
measure: Vein status
timeFrame: Measured at baseline
measure: Vein status
timeFrame: Measured after five weeks of training/controll
measure: Vein status
timeFrame: Measured after eight weeks of training/control
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Southern Jutland
Study officials:
affiliation: Vejle Hospital
name: Hanne I Jensen, PhD
role: STUDY_CHAIR
References: