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NCT Number: NCT07418021

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

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.

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Key information

About this study

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.

Who can participate

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

Treatment and study plan

Cold Spray Intervention Group

Other

Cold spray application

Buzy Device Intervention Group

Other

Buzzy device application

Control Group

Other

Standard care

Primary outcomes

  1. Procedural Pain Intensity

    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."

Secondary outcomes

  1. Level of Procedural Fear

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sema K Kömürkara, Dr

CONTACT

[email protected]

+905396241442

Zeliha CENGIZ, Associate Professor Dr.

CONTACT

[email protected]

+90543 327 7494 ext. +90543 327 749

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

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.

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