Palm Stimulator Use During Peripheral Venous Catheterization

NCT07387497 | Not Yet Recruiting DMC

• 1 other identifier: 2026/9255
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Fear Needles; Anxiety; Catheterization, Peripheral Venous; Procedural Pain

Keywords

Procedural Pain Management; Peripheral Venous Catheterization; Patient Satisfaction; Palm Stimulator; Oncology Nursing; Needle Fear; Tactile Stimulation

Outcome Measures

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."

  Within 1 minute after the completion of the peripheral venous catheterization procedure.

Secondary Outcomes (2)

• Level of Procedural Fear

  Immediately before the procedure and within 1 minute after the procedure.

• Patient Satisfaction With the Procedure

  Within 1 minute after the completion of the procedure.

Other Outcomes (1)

• Satisfaction With the Palm Stimulator

  Within 5 minutes after the procedure.

Study Arms (2)

Palm Stimulator Group

EXPERIMENTAL

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.

Device: Palm Stimulator Group

Control group

NO INTERVENTION

Participants will receive the standard routine PVC protocol. No additional intervention will be provided during the procedure.

Interventions

Palm Stimulator Group DEVICE

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.

Palm Stimulator Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeliha CENGİZ: lead

Study Sites (1)

Turgut Ozal Medical Center

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Neoplasms; Iatrophobia; Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Zeliha Cengiz, Associate Professor

CONTACT

+905433277494; zeliha.cengiz@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)