Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients

NCT06624761 | Not Yet Recruiting

• 1 other identifier: E-79438647-108-48697 TU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind study aimed to determine the effect of ShotBlocker on IMI pain in adult patients who received diclofenac sodium and metamizole sodium as IMI in the emergency department. The main question(s) it aims to answer are as follows: • \[Is there a difference between the pain score averages between the intervention group and the control group after ShotBlocker? Participants \[Participants in both groups are individuals who applied to the emergency department and received IM injections according to the doctor\'s order.\] If there is a comparison group: Researchers will make a comparison with the control group.

Conditions

Patients Above 18 Years

Keywords

ShotBlocker; intramuscular injection pain; nursing

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the individual can indicate their own pain by drawing a line, putting a dot, or pointing between the 10 cm (100 mm) section of the ruler where there is no pain (zero) on one end and the most severe pain on the other end. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters and the value found indicates the individual\'s pain intensity. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm reflects severe pain.

  12 week.

Study Arms (2)

ShotBlocker

EXPERIMENTAL

ShotBlocker will be applied to the experimental group.

Device: ShotBlocker

Control group

NO INTERVENTION

no intervention will be made

Interventions

ShotBlocker DEVICE

A randomized study investigating ShotBlocker in painkillers containing different active ingredients could not be found.

ShotBlocker

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 and over who speak Turkish,
• Who have signed the informed consent form,
• Who are admitted to the emergency room for prescription drug use or who are planned to use diclofenac sodium and metamizole sodium as IMI upon the directive of the emergency room physician will constitute.

You may not qualify if:

• Pregnant women,
• Those with psychiatric disorders,
• Those with hearing or vision problems,
• Those who applied to the red area of the emergency room,
• Those with impaired consciousness,
• Those with secondary injuries and infections at the injection site,
• Those who have previously received an injection at the same site within the last 24 hours, -Those who did not sign the informed consent form for the study

Sponsors & Collaborators

• Yağmur SÜRMELİ: lead
• Toros University: collaborator

Study Sites (1)

Toros State Hospital

Mersin, Adana, Mersin, 33110, Turkey (Türkiye)

Location

Study Officials

• YAGMUR SÜRMELI, DR.

  Toros University

  STUDY DIRECTOR

Central Study Contacts

YAGMUR SURMELI, DR.

CONTACT

+905385701923; demetyagmurdemet@gmail.com

BEHİRE SANÇAR, Dr.

CONTACT

+905385701923

Study Design

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

Model Details: There will be 2 groups (ShotBlocker and control )

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 3, 2024
• Study Start: October 14, 2024
• Primary Completion: December 30, 2024
• Study Completion: April 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)