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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-07/02 | Other Identifier | Sivas Cumhuriyet University Faculty of Medicine Clinical Research Ethics Committee decision number |
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| Name | Class |
|---|---|
| Tokat Gaziosmanpasa University | OTHER |
| TOKI Family Health Centre | UNKNOWN |
| Sivas Provincial Health Directorate | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intramuscular Injection | Active Comparator | 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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| Internal Rotation of the Extremity | Experimental | 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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| Local Cold Application | Experimental | 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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| ShotBlocker | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard intramuscular injection | Procedure | Standard ventrogluteal intramuscular cyanocobalamin injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity during intramuscular 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. | Immediately after each injection |
| Comfort during intramuscular 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. | Immediately after each injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and comfort by participant characteristics | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuba Karabey | Tokat Gaziosmanpasa University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOKI Family Health Centre | Sivas | Turkey (Türkiye) |
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.
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Each participant received all four injection techniques across four visits in a randomized, counterbalanced Latin-square order.
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Participants and the administering nurse were not blinded because the procedures were visibly distinct. The outcome assessor who entered and analyzed pain and comfort scores was blinded to sequence assignment until the database was locked.
| Internal rotation of the extremity | Procedure | Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection. |
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| Local cold application | Procedure | Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection. |
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| ShotBlocker | Device | ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal. |
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