AzTrials
AzTrials

Procedural PainNCT07387497

Palm Stimulator Use During Peripheral Venous Catheterization

A study testing Palm Stimulator Group in people with Procedural Pain and Cancer, run by Zeliha CENGİZ at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Procedural Pain, Cancer, Fear Needles
What is being tested?
Palm Stimulator Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2026to 30 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zeliha Cengiz, Associate Professor contact

+905433277494

zeliha.cengiz@inonu.edu.tr

Turkey (Türkiye)1 site
  • Turgut Ozal Medical Center

    Malatya, Malatya, 44000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Palm Stimulator Use During Peripheral Venous Catheterization on Pain, Fear, and Procedural Satisfaction in Cancer Patients Receiving Chemotherapy

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.

Read more

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.

Read the 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.

Being tested
Palm Stimulator Group
Keywords
Procedural Pain Management, Peripheral Venous Catheterization, Patient Satisfaction, Palm Stimulator, Oncology Nursing, Needle Fear, Tactile Stimulation
Medical subject headings
Pain, Procedural, Neoplasms, Iatrophobia, Anxiety Disorders, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palm Stimulator GroupDevice

    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.

Study groups in NCT07387497
Study groupRoleWhat they receive
Palm Stimulator GroupExperimental1-2 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.
Receives: Device: Palm Stimulator Group
Control groupNo interventionParticipants will receive the standard routine PVC protocol. No additional intervention will be provided during the procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

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

Secondary outcomes (2)
  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).

    Measured: 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."

    Measured: Within 1 minute after the completion of the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start20 Feb 2026 (estimated)
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387497
Sponsor's protocol ID
2026/9255
Status last verified
Feb 2026
First submitted
28 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with third parties or publicly to ensure the full protection of patient privacy and confidentiality, in accordance with the Law on the Protection of Personal Data (KVKK) and institutional ethical guidelines. The informed consent obtained from the participants does not include permission for the public sharing of raw individual data. Only de-identified, aggregated study results and statistical summaries will be presented through peer-reviewed publications and conference presentations to contribute to the scientific literature.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 41289974

Questions about this trial

What is this clinical trial studying?

A study testing Palm Stimulator Group in people with Procedural Pain and Cancer, run by Zeliha CENGİZ at 1 site in Turkey (Türkiye).

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 4 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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zeliha Cengiz, Associate Professor (+905433277494, zeliha.cengiz@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Pain Intensity (time frame: Within 1 minute after the completion of the peripheral venous catheterization procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387497, which also lists 5 linked publications.

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 6 Feb 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in