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This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections.
Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools.
The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.
This randomized controlled study will be conducted to evaluate the effects of cold spray and the Buzzy device on pain and fear associated with penicillin injection. Eligible participants who require intramuscular penicillin injection will be randomly assigned to one of the study groups: cold spray, Buzzy device, or routine care (control group).
In the cold spray group, a topical cold spray will be applied to the injection site immediately before the injection. In the Buzzy device group, the Buzzy device will be placed near the injection site to provide cold and vibration during the injection. Participants in the control group will receive the injection according to standard clinical practice without any additional intervention.
Pain and fear levels will be assessed during the injection process using validated measurement tools. Data collection will be carried out by trained researchers following standardized procedures. The study will be conducted in accordance with ethical principles and relevant clinical research guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | In the Control group, a standard intramuscular penicillin injection is administered without any additional pain management intervention. All injections are performed using a standardized technique by the same nurse to ensure consistency. |
|
| Cold Spray Intervention Group | Experimental | Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. |
|
| Buzy Device Intervention Group | Experimental | Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Spray Intervention Group | Other | Cold spray application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Pain Intensity | Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain." | Within one minute before the penicillin injection procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Procedural Fear | The level of fear regarding the injection will be assessed using the Visual Analog Scale (VAS-Fear), where 0 indicates "no fear" and 10 indicates "extreme fear." This assessment will be performed both before the procedure (pre-test) and after the procedure (post-test). | Immediately before the procedure and within 1 minute after the procedure. |
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Eligibility Criteria
Inclusion Criteria:
Adults aged 18 years and older
Individuals scheduled to receive intramuscular penicillin injection
Able to communicate and report pain and fear levels
Willing to participate in the study
Provided written informed consent
Exclusion Criteria:
Known allergy or hypersensitivity to cold applications
Skin lesions, infection, or injury at the injection site
Neurological or psychiatric conditions that may affect pain or fear perception
Use of analgesic or anxiolytic medication prior to injection
Previous adverse reaction to intramuscular injections
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeliha CENGIZ, Associate Professor Dr. | Contact | +90543 327 7494 | +90543 327 749 | zeliha.cengiz@inonu.edu.tr |
| Sema K Kömürkara, Dr | Contact | +905396241442 | sema.komurkara@inonu.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Yildiz GN, Ciftci B; Development of the Injection Fear Scale; Proceedings of the 1st International UludaÄŸ Scientific Research Congress; 2023:1-2. | ||
| Result | Çetin MM, Avşar G; Evaluation of the effect of cold spray application on injection pain during intramuscular penicillin injection; Mersin University Journal of Health Sciences; 2022;15(3):573-583. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| C000719205 | Iatrophobia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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A randomized controlled experimental study with 3 groups.
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| Buzy Device Intervention Group |
| Other |
Buzzy device application |
|
| Control Group | Other | Standard care |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |