Actively Recruiting
ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction
Led by Necmettin Erbakan University · Updated on 2026-01-12
132
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Reducing injection-related pain should be a priority in nursing care for both patient safety and the effectiveness of the treatment process. This study is a triple-blind, randomized, controlled trial. It was designed to evaluate the effects of ShotBlocker, cold needle, and a combination of both methods during intramuscular injection on patient pain levels and satisfaction. The research will be conducted in the injection unit affiliated with the Adult Emergency Department of Konya City Hospital, Ministry of Health of the Republic of Turkey. The study population will consist of patients who presented for cyanocobalamin injections, and the sample will consist of 132 individuals who voluntarily agreed to participate in the study and met the inclusion criteria. Before conducting the study, ethical approval will be obtained from the Necmettin Erbakan University Health Sciences Ethics Committee and from the Konya City Hospital of the Ministry of Health of the Republic of Turkey. Collected data will be analyzed using the SPSS statistical package program (version 22.0; SPSS Inc., USA). The Kolmogorov-Smirnov test will be used to assess whether the data exhibit a normal distribution; statistical significance will be accepted as p\<0.05.
CONDITIONS
Official Title
ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be between 18 and 65 years of age.
- Must be able to speak and understand Turkish.
- Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin for intramuscular injection.
- Must receive the injection in the deltoid region.
- Must not be in the menstrual cycle.
- Must not be pregnant.
- Must have no history of diabetes.
- Must have a Body Mass Index (BMI) between 18.5 and 30.
- Must have no scars, incisions, lipodystrophy, or infection at the injection site.
- Must have no history of allergy to the medication.
- Must not have any illness preventing perception of variables such as vision, hearing, sensory loss, cognitive impairment, or stroke.
- Must not be using centrally or peripherally acting analgesics or sedatives.
- Must not have limb impairments.
- Must have a Visual Analogue Scale (VAS) pain score of "0" before injection.
- Must agree to participate in the study.
You will not qualify if you...
- Chronic or acute pain.
- Receiving oral or parenteral analgesic treatment before the study.
- Receiving another injection in the deltoid region.
- Developing a drug-related allergy or other complication.
- Having a contact-related infectious disease.
- Participants wishing to withdraw from the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Necmettin Erbakan University
Konya, Turkey (Türkiye)
Actively Recruiting
Research Team
Y
Yadigar Yadigar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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