Palm Stimulator Use During Peripheral Venous Catheterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palm Stimulator Group.
- Who it may be relevant to
- Registry conditions: Procedural Pain, Cancer, Fear Needles, Anxiety. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Palm Stimulator Use During Peripheral Venous Catheterization on Pain, Fear, and Procedural Satisfaction in Cancer Patients Receiving Chemotherapy
Overview
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.
Detailed description
Background: Cancer remains a complex disease that threatens individuals' lives across biopsychosocial dimensions. According to the World Health Organization, more than 19 million new cancer cases were diagnosed globally in 2020 (Sung et al., 2021). In modern oncology, chemotherapy is a primary treatment modality, with approximately 75% of these treatments administered intravenously (Duggan et al., 2024). Consequently, patients undergo repeated invasive procedures such as peripheral venous catheterization (PVC). Although PVC is a routine clinical task, it is a significant source of stress associated with pain, fear, and dissatisfaction. Inadequate management of procedural pain can lead to increased pain perception through peripheral and central sensitization, resulting in anticipatory anxiety and healthcare avoidance behaviors (Kapucu et al., 2017; Özırmak \& Yayan, 2026).Oncology nurses bear critical responsibility in utilizing non-pharmacological methods to enhance patient comfort. Due to the side effects and cost limitations of pharmacological interventions, there is a need for low-cost, easy-to-integrate alternative approaches. While tactile stimulation-based interventions are promising, evidence regarding neurophysiologically based palmar stimulation is limited (Moustafa, 2024; Zengin \& Yayan, 2022). The palm of the hand occupies a large representation area in the somatosensory cortex, allowing tactile stimuli from this region to be processed intensely by the central nervous system. Based on the Gate Control Theory, gripping the "Palm Stimulator" provides rapid sensory input that can inhibit pain perception at a neurophysiological level (Özırmak \& Yayan, 2026).
Study Design and Setting: This study is designed as a randomized controlled clinical trial. It will be conducted at the Oncology Unit of Inönü University Turgut Ozal Medical Center between February and July 2026.
Intervention Protocol: Participants will be randomized into two groups using Research Randomizer software:
Palm Stimulator Group: 1-2 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.
Control Group: Participants will receive the standard routine PVC protocol. No additional intervention will be provided during the procedure.
Standardization: To ensure consistency, PVC procedures will be performed by nurses with at least one year of clinical experience. Standard 20G, 22G, or 24G catheters will be used. The Palm Stimulator (Utility Model No: 06479) will be disinfected with alcohol-based solutions between each use.
Data Collection and Tools: Data will be collected using face-to-face interviews and standardized scales:
Patient Identification Form: Demographic and clinical data (age, gender, diagnosis, chemotherapy cycle, etc.).
Visual Analog Scale (VAS): A 10 cm horizontal scale used to measure:Pre-procedural fear (0 = no fear, 10 = extreme fear).Post-procedural pain (0 = no pain, 10 = unbearable pain).Post-procedural satisfaction (0 = not satisfied, 10 = very satisfied).
Statistical Analysis:Data will be analyzed using IBM SPSS. Descriptive statistics (mean, SD, percentages) will be used for demographics. Normality will be tested via the Kolmogorov-Smirnov test. Independent Samples t-test or Mann-Whitney U test will be utilized for group comparisons. Pearson/Spearman correlation and ANCOVA will be performed to evaluate the relationship between pain scores and variables such as age or catheter size. The significance level is set at p \< 0.05.
Interventions
- Device Palm Stimulator Group
1-2 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.
Primary outcome measures
- Procedural Pain Intensity [Time frame: Within 1 minute after the completion of the peripheral venous catheterization procedure.]
Secondary outcome measures (2)
- Level of Procedural Fear [Time frame: Immediately before the procedure and within 1 minute after the procedure.]
- Patient Satisfaction With the Procedure [Time frame: Within 1 minute after the completion of the procedure.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Turgut Ozal Medical Center — Malatya
Publications
- Zengin M, Yayan EH. A Comparison of Two Different Tactile Stimulus Methods on Reducing Pain of Children During Intramuscular Injection: A Randomized Controlled Study. J Emerg Nurs. 2022 Mar;48(2):167-180. doi: 10.1016/j.jen.2021.10.006. Epub 2021 Dec 22. PMID 34952709
- Kapucu S, Ozkaraman AO, Uysal N, Bagcivan G, Seref FC, Eloz A. Knowledge Level on Administration of Chemotherapy through Peripheral and Central Venous Catheter among Oncology Nurses. Asia Pac J Oncol Nurs. 2017 Jan-Mar;4(1):61-68. doi: 10.4103/2347-5625.199081. PMID 28217732
- Duggan C, Hernon O, Dunne R, McInerney V, Walsh SR, Lowery A, McCarthy M, Carr PJ. Vascular access device type for systemic anti-cancer therapies in cancer patients: A scoping review. Crit Rev Oncol Hematol. 2024 Apr;196:104277. doi: 10.1016/j.critrevonc.2024.104277. Epub 2024 Mar 14. PMID 38492760
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- Ozirmak N, Yayan EH. The difference between site of application and pain relief efficacy of the palm stimulator: A randomised controlled trial of intravenous blood drawn in children. J Pediatr Nurs. 2026 Jan-Feb;86:315-323. doi: 10.1016/j.pedn.2025.11.022. Epub 2025 Nov 24. PMID 41289974
Identifiers
NCT: NCT07387497 · 2026/9255