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Completed

NCT Number: NCT07623421

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOKI Family Health Centre

Sivas, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard intramuscular injection

Procedure

Standard ventrogluteal intramuscular cyanocobalamin injection.

Internal rotation of the extremity

Procedure

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

Local cold application

Procedure

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

ShotBlocker

Device

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

Other names: Bionix ShotBlocker

Primary outcomes

  1. Pain intensity during intramuscular injection

    Time frame: Immediately after each injection

    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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

MEDICANA

Unknown

Collaborators

  • Sivas Provincial Health Directorate
  • TOKI Family Health Centre
  • Tokat Gaziosmanpasa University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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