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Effects of Cold Spray and Buzzy Device an Pain and Fear During Penicillin Injection

The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07418021
Enrollment
90
Registered
2026-02-18
Start date
2026-02-05
Completion date
2026-05-05
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear, Injection, Pain Management

Keywords

Pain, Injection, Injection fear

Brief summary

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.

Detailed description

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.

Interventions

OTHERCold Spray Intervention Group

Cold spray application

OTHERBuzy Device Intervention Group

Buzzy device application

OTHERControl Group

Standard care

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

A randomized controlled experimental study with 3 groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Procedural Pain IntensityWithin 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."

Secondary

MeasureTime frameDescription
Level of Procedural FearImmediately 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).

Contacts

CONTACTZeliha CENGIZ, Associate Professor Dr.
zeliha.cengiz@inonu.edu.tr+90543 327 7494
CONTACTSema K Kömürkara, Dr
sema.komurkara@inonu.edu.tr+905396241442

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026