Comparison of Internal Rotation, Local Cold and ShotBlocker on Intramuscular Injection Pain and Comfort
May 28, 2026 updated by: Ahmet Altun, MEDICANA
Comparison of Internal Rotation of the Extremity, Local Cold Application and ShotBlocker on Pain and Comfort During Ventrogluteal Intramuscular Cyanocobalamin Injection: A Randomized Counterbalanced Within-Subjects Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Adults aged 18 years or older who presented to TOKI Family Health Centre in Sivas, Turkey for prescribed cyanocobalamin intramuscular injection were enrolled between July and December 2019.
Each participant received all four ventrogluteal injection techniques across four visits scheduled 24-48 hours apart.
The order of techniques was randomized and counterbalanced using a 4 x 4 Latin-square sequence, with allocation concealed in sealed, opaque, sequentially numbered envelopes.
Blinding of participants and the administering nurse was not feasible because the procedural techniques were visibly distinct, but the outcome assessor who entered and analyzed pain and comfort scores was blinded to sequence assignment until database lock.
All injections were administered by the same experienced registered nurse using cyanocobalamin 1 mg in 1 mL and a 22-gauge, 38-mm needle.
Pain was assessed using a 0-10 Visual Analogue Scale and comfort using a 0-10 numerical comfort scale immediately after each injection.
Study Type
Interventional
Enrollment (Actual)
215
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sivas, Turkey (Türkiye)
- TOKI Family Health Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Presented to the family health centre for a prescribed course of cyanocobalamin intramuscular injection.
- Able to read, understand, and respond to study instruments in Turkish.
- Provided written informed consent.
Exclusion Criteria:
- Contraindication to ventrogluteal intramuscular injection.
- Local skin lesion, inflammation, edema, scarring, or sensory disturbance over either ventrogluteal site.
- Body mass index less than 18.5 or greater than 35 kg/m2.
- Concurrent regular analgesic or anti-inflammatory use.
- Chronic pain condition.
- Clinically diagnosed psychiatric disorder under active treatment.
- Pregnancy or lactation.
- Known cold intolerance, cold urticaria, or Raynaud phenomenon.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Intramuscular Injection
Ventrogluteal intramuscular injection using standard positioning, skin antisepsis, 90-degree needle insertion, cyanocobalamin 1 mg/1 mL delivered over 5 seconds, and gauze after withdrawal without massage.
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Standard ventrogluteal intramuscular cyanocobalamin injection.
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Experimental: Internal Rotation of the Extremity
Standard ventrogluteal injection with the participant internally rotating the foot of the injection-side leg so the great toe points medially from immediately before needle insertion until needle withdrawal.
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Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection.
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Experimental: Local Cold Application
A 10 x 10 cm cold gel pack stored at -18 degrees C, wrapped in clean cotton gauze, was applied to the injection site for 3 minutes before skin antisepsis and otherwise standard injection.
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Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection.
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Experimental: ShotBlocker
A U-shaped ShotBlocker device was placed over the injection site with firm contact between the blunt projections and the skin during needle insertion, medication delivery, and withdrawal; the injection was otherwise standard.
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ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity during intramuscular injection
Time Frame: Immediately after each injection
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Participant-reported pain measured immediately after each injection using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
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Immediately after each injection
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Comfort during intramuscular injection
Time Frame: Immediately after each injection
|
Participant-reported comfort measured immediately after each injection using a 0-10 numerical comfort scale, where 0 indicates extremely uncomfortable and 10 indicates extremely comfortable.
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Immediately after each injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain and comfort by participant characteristics
Time Frame: Immediately after each injection
|
Pain and comfort scores were examined by sex, age group, body mass index category, educational background, and previous intramuscular injection experience.
|
Immediately after each injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tuba Karabey, Tokat Gaziosmanpasa University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 9, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
May 28, 2026
First Submitted That Met QC Criteria
May 28, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IMPAIN-2019-SIVAS
- 2019-07/02 (Other Identifier: Sivas Cumhuriyet University Faculty of Medicine Clinical Research Ethics Committee decision number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The datasets generated and analyzed during the study are not publicly available because the participant consent form did not include explicit permission for open data sharing.
Data may be available from the corresponding author on reasonable request and subject to local ethics governance approval.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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