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

February 10, 2026 updated by: Zeliha CENGİZ, Inonu University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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.
Other: Control Group
Standard care
Experimental: Cold Spray Intervention Group
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.
Other: Cold Spray Intervention Group
Cold spray application
Experimental: Buzy Device Intervention Group
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.
Other: Buzy Device Intervention Group
Buzzy device application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Within one minute before the penicillin injection procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately before the procedure and within 1 minute after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Yildiz GN, Ciftci B; Development of the Injection Fear Scale; Proceedings of the 1st International Uludağ Scientific Research Congress; 2023:1-2.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2026

Primary Completion (Estimated)

April 5, 2026

Study Completion (Estimated)

May 5, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/8735

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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