TOKI Family Health Centre
Sivas, Turkey (Türkiye)
NCT Number: NCT07623421
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sivas, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard ventrogluteal intramuscular cyanocobalamin injection.
Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection.
Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection.
ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal.
Other names: Bionix ShotBlocker
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.
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.
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.
MEDICANA
Unknown
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
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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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