Comparison of Internal Rotation, Local Cold and ShotBlocker on Intramuscular Injection Pain and Comfort

NCT07623421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2026-06-03

No results posted yet for this study

Summary

This single-centre, randomized, counterbalanced, within-subjects clinical trial compared four techniques for reducing pain and improving comfort during ventrogluteal intramuscular cyanocobalamin injection in adults. Participants presenting to a family health centre for prescribed vitamin B12 injection each received four injections, one with each technique: standard injection, internal rotation of the extremity, local cold application, and ShotBlocker. Technique order was assigned using a 4 x 4 Latin-square randomization. Pain and comfort were measured immediately after each injection using 0-10 participant-reported scales.

Conditions

  • Intramuscular Injection Pain
  • Patient Comfort

Interventions

PROCEDURE

Standard intramuscular injection

Standard ventrogluteal intramuscular cyanocobalamin injection.

PROCEDURE

Internal rotation of the extremity

Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection.

PROCEDURE

Local cold application

Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection.

DEVICE

ShotBlocker

ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal.

Sponsors & Collaborators

  • Tokat Gaziosmanpasa University

    collaborator OTHER
  • TOKI Family Health Centre

    collaborator UNKNOWN
  • Sivas Provincial Health Directorate

    collaborator UNKNOWN
  • MEDICANA

    lead UNKNOWN

Principal Investigators

  • Tuba Karabey · Tokat Gaziosmanpasa University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623421 on ClinicalTrials.gov