NCT06947525

Brief Summary

This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method. Research Hypotheses

  • H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
  • H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
  • H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
  • H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    The minimum score on the scale is 0 and the maximum score is 10. A score of 0 indicates no pain, while a score of 10 indicates unbearable pain.

    The peripheral venous catheter will be filled within 1 minute after insertion.

Secondary Outcomes (1)

  • Patient Satisfaction Scale

    The peripheral venous catheter will be filled within 1 minute after insertion.

Study Arms (3)

Manual pressure

EXPERIMENTAL

Before placing a peripheral intravenous catheter in the manual pressure group, the vein entry area will be pressed with the right thumb for 10 seconds. The pressure will be applied until the nail bed turns white.

Other: Manual pressure

Shotblocker

EXPERIMENTAL

In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure.

Other: Shotblocker

Control

NO INTERVENTION

The control group will undergo standard peripheral catheter placement without any intervention.

Interventions

Before the procedure in the manual pressure group, the vein entry area will be pressed with the right hand thumb for 10 seconds. The pressure will be applied until the nail bed turns white.

Manual pressure

In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure.

Shotblocker

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to the urology clinic,
  • No verbal, perceptual and visual communication problems,
  • Between the ages of 18 and 65,
  • Literate,
  • Volunteer to participate in the study,
  • Not using medication that will create a chronic analgesic effect,
  • Not having chronic or acute pain,
  • No intervention has been performed on the vein where the PIC is placed in the last month,
  • No scar tissue or infection in the areas where the PIC will be placed,
  • Not having a disease that will cause problems in feeling pain (such as neuropathy)

You may not qualify if:

  • The individual wants to leave the study,
  • Feels unwell during the PIC placement (such as dizziness, palpitations),
  • Uses sedatives or alcohol,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD, RN

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

April 28, 2025

Primary Completion

April 28, 2025

Study Completion

June 30, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share