ShotBlocker, cold needling, or both to reduce pain and improve satisfaction with intramuscular B12 injections

The Effects of Intramuscular Injection Using ShotBlocker, Cold Needling, and Both Methods in Combination on Pain and Satisfaction: A Randomized Controlled Trial

This will test ShotBlocker, cold needling, or both to see which reduces pain and improves satisfaction for adults receiving a deltoid cyanocobalamin (B12) intramuscular injection.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Necmettin Erbakan University (other)
• Locations: 1 site (Konya)
• Trial ID: NCT07258953 on ClinicalTrials.gov

What this trial studies

This triple-blind, randomized, controlled trial will enroll 132 adults receiving a 1000 mcg cyanocobalamin intramuscular injection in the deltoid at the injection unit of Konya City Hospital. Participants will be randomized to one of four groups: ShotBlocker, cold needling, the combination of both, or control, with pain (VAS) and patient satisfaction recorded before and after injection. Key exclusions include pregnancy, diabetes, BMI outside 18.5–30, active problems at the injection site, recent use of central or peripheral analgesics, sensory or cognitive impairment, and current menstrual cycle. Standardized injection technique and blinding procedures will be used to minimize bias.

Who should consider this trial

Good fit: Adults 18–65 who speak Turkish, are prescribed a 1 ml (1000 mcg) cyanocobalamin deltoid IM injection, have BMI 18.5–30, are not pregnant or diabetic, and are not using analgesics would be eligible.

Not a fit: People who are pregnant, diabetic, outside the 18–65 age range, have BMI outside 18.5–30, have injection-site scars/infection, are on analgesic or sedative medications, or are receiving injections at a different site would not be expected to qualify or benefit.

Why it matters

Potential benefit: If successful, these low-cost methods could reduce injection pain and increase patient satisfaction during routine intramuscular B12 injections.

How similar studies have performed: Previous smaller trials of vibratory devices like ShotBlocker and of cold application during injections have shown reduced pain in some settings, so the approach builds on mixed but supportive prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Must be between 18 and 65 years of age.
2. Must have no problems speaking and understanding Turkish.
3. Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin IM injection.
4. Must use the deltoid region for the injection.
5. Must not be in the menstrual cycle.
6. Must not be pregnant.
7. Must have no history of diabetes.
8. Must have a Body Mass Index (BMI) between 18.5 and 30.
9. Must have no scars, incisions, lipodystrophy, or infection at the injection site.
10. Must have no history of allergy to the medication.
11. Must have no pain, fear, etc. The inclusion criteria for the study were: not having any illness that prevents the perception of variables (vision, hearing, sensory loss, cognitive impairment, stroke, etc.),
12. not using centrally or peripherally acting analgesics or sedatives,
13. not having limb impairments,
14. having a VAS score of "0" before the injection,
15. agreeing to participate in the study.

Exclusion Criteria:

1. Chronic or acute pain,
2. Receiving oral or parenteral analgesic treatment before the study,
3. Receiving another injection in the deltoid region,
4. Developing a drug-related allergy or other complication,
5. Having a contact-related infectious disease,
6. Participants wishing to withdraw from the study.

Where this trial is running

Konya

• Necmettin Erbakan University — Konya, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Yadigar Yadigar — Necmettin Erbakan University
• Study coordinator: Yadigar Yadigar

Conditions: Pain