Cold Spray Intervention Group
OtherCold spray application
NCT Number: NCT07418021
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Cold spray application
Buzzy device application
Standard care
Time frame: Within one minute before the penicillin injection procedure.
Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain."
Time frame: Immediately before the procedure and within 1 minute after the procedure.
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).
Contact information is provided by the study sponsor or research team.
Sema K Kömürkara, Dr
CONTACT
Zeliha CENGIZ, Associate Professor Dr.
CONTACT
+90543 327 7494 ext. +90543 327 749
Inonu University
Other
The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06790550
Diabetes Mellitus, Diabetes Mellitus, Type 2
Diyarbakır, South East, Turkey (Türkiye)
View Trial DetailsNCT07367659
Fear, Injection
Sakarya, Turkey (Türkiye)
View Trial DetailsNCT06760559
Assessment, Behavior
Tel Aviv, Israel
View Trial DetailsNCT05230667
Adhesive Capsulitis, Bursitis
Taipei, Taiwan
View Trial Details