Injection Site Pain
Conditions
Keywords
Cold needle technique, Intramuscular injection, Ventrogluteal site, Pain intensity, Patient satisfaction, Randomized controlled trial
Brief summary
This randomized controlled trial aims to evaluate the effect of the cold needle technique on pain and patient satisfaction during intramuscular injections administered to the ventrogluteal site. The study was conducted in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye. A total of 78 adult patients receiving intramuscular vitamin B12 injections as part of their prescribed treatment participated in the study. Participants were randomly assigned to an intervention group (n=40) or a control group (n=38). The intervention group received intramuscular injections using a cooled needle, while the control group received injections using the standard technique. Only the injection needle was cooled; the medication was not cooled. Pain intensity and patient satisfaction were assessed after the injection using Visual Analog Scales (VAS). The study aims to determine whether the cold needle technique reduces injection-related pain and improves patient satisfaction compared with the standard intramuscular injection technique.
Detailed description
This study was designed as a randomized controlled trial to investigate the effects of the cold needle technique on pain intensity and patient satisfaction during intramuscular injections administered to the ventrogluteal site. The study included 78 adult patients who were receiving intramuscular vitamin B12 (cyanocobalamin) injections as part of their prescribed treatment in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye. Participants were randomly allocated to two groups: an intervention group consisting of 40 patients and a control group consisting of 38 patients. In the intervention group, sterile injection needles were cooled in an insulated container containing ice packs. The temperature was monitored using a thermometer. Immediately before the injection, the cooled needle was removed from its sterile packaging and attached to the syringe under aseptic conditions. Only the needle was cooled; the medication and syringe were not refrigerated. In the control group, intramuscular injections were administered using the standard technique without cooling the needle. All injections were administered to the ventrogluteal site by the same researcher. The injection procedure was otherwise identical in both groups. Following the injection, participants assessed their pain intensity and satisfaction using Visual Analog Scales (VAS), with scores ranging from 0 to 10. The primary outcome was injection-related pain intensity, and the secondary outcome was patient satisfaction.
Interventions
PROCEDURECold Needle Technique
Sterile injection needles were cooled in an insulated container containing ice packs. Needle temperature was monitored using a thermometer. Immediately before administration, the cooled needle was attached to the syringe under aseptic conditions. Only the needle was cooled; the vitamin B12 medication and syringe were not cooled. The injection was administered into the ventrogluteal site.
PROCEDUREStandard Intramuscular Injection
Participants received intramuscular vitamin B12 injections into the ventrogluteal site using a standard, non-cooled sterile injection needle. The injection procedure was otherwise identical to that used in the intervention group.
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants were unaware of their group assignments. The researcher administering the injections was not blinded because the intervention required the use of a cooled needle. Participants completed the pain and satisfaction Visual Analog Scales themselves. The statistical analysis was performed using coded group labels
Intervention model description
This study used a parallel-group randomized controlled design. A total of 78 patients were allocated to two groups: an intervention group receiving intramuscular injections with a cooled needle (n=40) and a control group receiving standard intramuscular injections (n=38). All injections were administered to the ventrogluteal site by the same researcher.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older. * Receiving a prescribed intramuscular vitamin B12 injection. * No cognitive impairment. * Able to communicate effectively. * Willing to participate in the study and provide informed consent.
Exclusion criteria
* Presence of a skin disease or infection at the injection site. * Diagnosis of a neurological or psychiatric disorder. * History of opioid use that may affect pain perception. * Diagnosis of diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Following Intramuscular Injection | Immediately after the intramuscular injection | Pain intensity was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Following Intramuscular Injection | Immediately after the intramuscular injection | Patient satisfaction was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores indicate greater patient satisfaction. |
Countries
Turkey (Türkiye)
Outcome results
None listed