- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704502
The Effect of Isometric Exercise and Dry Heat Application on PIVC
The Effect of Isometric Exercise and Dry Heat Application on Venous Fullness and Vein Visibility in Cancer Patients: A Randomized Controlled Trial
Purpose: This study was conducted to evaluate the effect of isometric exercise and dry heat application technique on venous fullness and vein visibility in cancer patients.
Design: This study is a randomized controlled trial model. Methods: This study was conducted in the outpatient chemotherapy unit of Malatya Turgut Ozal Medical Center Oncology Hospital, Türkiye. A total of 180 patients were enrolled and randomly allocated using block randomization to an isometric exercise group (n = 60), a dry heat application group (n = 60), or a control group (n = 60). Sample size was determined through power analysis. Data were collected using the "Descriptive Information Form", "Vein Rating Scale" and "Vein Assessment Tool".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients admitted to the chemotherapy unit were approached before treatment and informed about the purpose and procedures of the study. Eligibility was assessed according to the inclusion criteria, and written informed consent was obtained from all patients who met the eligibility criteria and voluntarily agreed to participate.
The data collection procedure consisted of the following steps:
Baseline assessment: Participants first completed the socio-demographic section of the Patient Information Form, and the responses were recorded by the researcher.
Pre-intervention vein assessment: A tourniquet was applied to the patient's upper extremity, and vein characteristics were assessed by the nurse using the Vein Rating Scale (VRS) and the Vein Assessment Tool (VAT). During this assessment, no manoeuvres intended to enhance vein visibility (e.g., repeated hand opening and closing, tapping, or slapping the vein) were permitted after tourniquet application. The tourniquet was then removed, and the patient rested for 10 minutes before baseline (pre-test) measurements were recorded.
Intervention: Participants received one of the study interventions according to their assigned group.
Isometric exercise group: Participants were provided with silicone hand exercise balls and instructed to squeeze and release the ball 15-20 times.
Dry heat application group: A chemical gel compress heated to 40 ± 2°C was applied to the selected extremity. Based on previous evidence, maintaining local heat at 40 ± 2°C for at least 5 minutes is sufficient to induce vasodilation.
Control group: Participants received routine peripheral intravenous catheterisation care without any additional intervention.
Post-intervention vein assessment: Immediately after completion of the intervention, a tourniquet was reapplied, and vein characteristics were reassessed by the nurse using the VRS and VAT. These measurements constituted the post-test assessment.
Peripheral intravenous catheterisation: Following the post-test assessment, peripheral intravenous catheterisation was performed by the chemotherapy nurse according to standard clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Malatya
-
Malatya, Malatya, Turkey (Türkiye), 44280
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergoing chemotherapy treatment,
- Receiving at least 3 cycles of chemotherapy treatment,
- Not diagnosed with diabetes and/or without peripheral neuropathy,
- Not receiving antithrombotic therapy,
- Without bleeding tendency and thrombocytopenia,
- No deep vein thrombosis,
- No complications associated with PIVC (such as ecchymosis, hematoma, scarring, edema, infiltration, extravasation and phlebitis),
- No allergy or sensitivity to heat,
- No metal prosthesis in the extremity to be heat therapy applied,
- No limb deformity that would prevent performing isometric exercises,
- No communication problems,
- No history of paralysis
- Patients who volunteered to participate in the study were included.
Exclusion Criteria:
- Total mastectomy,
- With peripheral nerve disease,
- More than 2 peripheral IV catheters applied,
- Psychiatric illness,
- People with intellectual disabilities at a level that cannot perceive cognitive functions and
- Individuals who did not perform or did not want to perform the procedures applied during the research process were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isometric exercise group
Isometric exercise group: Participants were provided with silicone hand exercise balls and instructed to squeeze and release the ball 15-20 times.
|
articipants were provided with silicone hand exercise balls and instructed to squeeze and release the ball 15-20 times.
|
|
Experimental: Dry heat application group
A chemical gel compress heated to 40 ± 2°C was applied to the selected extremity.
Based on previous evidence, maintaining local heat at 40 ± 2°C for at least 5 minutes is sufficient to induce vasodilation.
|
A chemical gel compress heated to 40 ± 2°C was applied to the selected extremity.
Based on previous evidence, maintaining local heat at 40 ± 2°C for at least 5 minutes is sufficient to induce vasodilation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of isometric exercise
Time Frame: Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention
|
Participants were provided with silicone hand exercise balls and instructed to squeeze and release the ball 15-20 times.
Vein status is evaluated as the "Vein Rating scale" and the "Vein Assessment Tool".
There was a visual analog scale that could be graded from 1 to 10, which evaluated the satisfaction of the nurse with the procedure and the patient's satisfaction with the previous application and the current application.
The assessment of satisfaction level was performed after the IV catheter was inserted.
|
Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of dry heat application
Time Frame: Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention
|
Description: A chemical gel compress heated to 40 ± 2°C was applied to the selected extremity.
Based on previous evidence, maintaining local heat at 40 ± 2°C for at least 5 minutes is sufficient to induce vasodilation.
Vein status is evaluated as the "Vein Rating scale" and the "Vein Assessment Tool".
There was a visual analog scale that could be graded from 1 to 10, which evaluated the satisfaction of the nurse with the procedure and the patient's satisfaction with the previous application and the current application.
The assessment of satisfaction level was performed after the IV catheter was inserted.
|
Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hakime Aslan, Faculty of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HakimeAslann
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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