PainNCT05716217
Training of Arms to Reduce Pain With Peripheral Venous Catheter
A study testing Arm training in people with Pain and Cancer, run by Vejle Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Arm training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2023to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who cannot read and understand Danish
- Patients <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read more
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.
- Being tested
- Arm training
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm trainingOther
Daily arm training program
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Not described Receives: Other: Arm training |
| Normal care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured after eight weeks of training/control
Secondary outcomes (3)
Vein status
Number of useable veins (assessed via ultrasound)
Measured: Measured at baseline
Vein status
Number of useable veins (assessed via ultrasound)
Measured: Measured after five weeks of training/controll
Vein status
Number of useable veins (assessed via ultrasound)
Measured: Measured after eight weeks of training/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start28 Feb 2023
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Why it stopped: Changes in provision of chemotherapy have made it impossible to recruit patients according to the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group is randomly assigned to an 8-week daily arm training program. The other group receives normal care
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanne I Jensen, PhD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716217
- Sponsor's protocol ID
- Vein-project
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05716217
- Acronym / sponsor ID
- Vein-project
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in provision of chemotherapy have made it impossible to recruit patients according to the protocol
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- One group is randomly assigned to an 8-week daily arm training program. The other group receives normal care
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Arm training |
| Normal care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who cannot read and understand Danish
- Patients <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm trainingDaily arm training program | Other | Training group |
Primary outcome
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
Time frame: Measured at baseline
Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
Time frame: Measured after five weeks of training/control
Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)
Time frame: Measured after eight weeks of training/control
Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale
3 secondary outcomes
Vein status
Time frame: Measured at baseline
Vein status
Time frame: Measured after five weeks of training/controll
Vein status
Time frame: Measured after eight weeks of training/control
Results and safety
The study was stopped early (reason given: Changes in provision of chemotherapy have made it impossible to recruit patients according to the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne I Jensen, PhD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm training in people with Pain and Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Changes in provision of chemotherapy have made it impossible to recruit patients according to the protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain) (time frame: Measured at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.