Palm Stimulator Use During Peripheral Venous Catheterization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZeliha CENGİZ
About this trial
Purpose: The purpose of this study is to evaluate the effectiveness of a "Palm Stimulator" (a handheld device with blunt protrusions) in reducing pain, fear, and anxiety during peripheral venous catheterization (IV insertion) in adult cancer patients receiving chemotherapy.
Methods: This is a randomized controlled clinical trial. Participants will be randomly assigned to either the Experimental Group or the Control Group.
Experimental Group: During the IV insertion process, patients will hold and squeeze the Palm Stimulator in the palm of their non-procedural hand. The device is designed to provide intense tactile (touch) stimulation based on the "Gate Control Theory." Control Group: Patients will receive the standard routine care for IV insertion without any additional intervention.
Data Collection: Pain intensity will be measured using the Visual Analog Scale (VAS), while fear and anxiety levels will be assessed through VAS scales before and after the procedure. Patient satisfaction with the device will also be recorded.
Expected Outcome: The investigators hypothesize that the use of the Palm Stimulator will significantly decrease procedural pain and fear while increasing patient satisfaction compared to standard care. This study aims to provide a low-cost, non-pharmacological, and easy-to-use tool for oncology nurses to improve patient comfort during invasive procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years.
Receiving chemotherapy treatment via peripheral venous catheter (PVC).
Cognitively capable of communicating and responding to pain, fear, and satisfaction scales.
Volunteering to participate and providing written informed consent.
Disqualifiers
Diagnosis of chemotherapy-induced peripheral neuropathy or diabetic neuropathy.
Presence of active infection, open wound, scar tissue, or edema in the palm.
Use of analgesic medication within 4-6 hours before the procedure.
History of hemiplegia or movement restriction in the extremity to be used for the procedure.
Trial design
Design model
Parallel
Treatments tested in this trial
Palm Stimulator Group
Device1-2 minutes before the procedure, patients will receive a brief orientation regarding the device. 20 seconds before PVC insertion, the device will be placed in the palm of the non-procedural hand. Patients will grip the device as the nurse applies the tourniquet. The tactile stimulation will continue throughout the needle entry and catheter stabilization.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Palm Stimulator GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Procedural Pain Intensity
Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain."
Time frame
Within 1 minute after the completion of the peripheral venous catheterization procedure.Secondary outcomes
1
Level of Procedural Fear
The level of fear regarding the injection will be assessed using the Visual Analog Scale (VAS-Fear), where 0 indicates "no fear" and 10 indicates "extreme fear." This assessment will be performed both before the procedure (pre-test) and after the procedure (post-test).
Time frame
Immediately before the procedure and within 1 minute after the procedure.2
Patient Satisfaction With the Procedure
Patients' satisfaction with the catheterization process and the intervention (if applicable) will be evaluated using a Visual Analog Scale (VAS-Satisfaction), where 0 represents "not satisfied at all" and 10 represents "very satisfied."
Time frame
Within 1 minute after the completion of the procedure.Other outcomes
1
Satisfaction With the Palm Stimulator
Patients in the intervention group will be asked two additional questions to evaluate their satisfaction specifically with the Palm Stimulator and their willingness to use it again in future procedures.
Time frame
Within 5 minutes after the procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zeliha CENGİZ
Lead sponsor
Inonu University
Sponsor institution
Source ClinicalTrials.gov
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