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

NCT07418021 | Not Yet Recruiting

• 1 other identifier: 2025/8735
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Injection; Pain Management; Fear

Keywords

Pain; Injection; Injection fear

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Level of Procedural Fear

  Immediately before the procedure and within 1 minute after the procedure.

Study Arms (3)

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.

Other: Control Group

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.

Other: Cold Spray Intervention Group

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.

Other: Buzy Device Intervention Group

Interventions

Cold Spray Intervention Group OTHER

Cold spray application

Cold Spray Intervention Group

Buzy Device Intervention Group OTHER

Buzzy device application

Buzy Device Intervention Group

Control Group OTHER

Standard care

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Related Publications (2)

• Yildiz GN, Ciftci B; Development of the Injection Fear Scale; Proceedings of the 1st International Uludağ 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.

  RESULT

MeSH Terms

Conditions

Agnosia; Pain; Iatrophobia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Zeliha CENGIZ, Associate Professor Dr.

CONTACT

+90543 327 7494; zeliha.cengiz@inonu.edu.tr

Sema K Kömürkara, Dr

CONTACT

+905396241442; sema.komurkara@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: A randomized controlled experimental study with 3 groups.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 18, 2026
• Study Start: February 5, 2026
• Primary Completion: April 5, 2026
• Study Completion: May 5, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02