Effects of Cold Spray and Buzzy Device an Pain and Fear During Penicillin Injection
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cold Spray Intervention Group, Buzy Device Intervention Group, Control Group.
- Кому может быть актуально
- Состояния в реестре: Injection, Pain Management, Fear. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Cold Spray Intervention Group
Cold spray application - Другое Buzy Device Intervention Group
Buzzy device application - Другое Control Group
Standard care
Первичные конечные точки
- Procedural Pain Intensity [Срок оценки: Within one minute before the penicillin injection procedure.]
Вторичные конечные точки (1)
- Level of Procedural Fear [Срок оценки: Immediately before the procedure and within 1 minute after the procedure.]
Критерии участия
Eligibility Criteria
Критерии включения
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
Критерии исключения
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- 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.
Идентификаторы
NCT: NCT07418021 · 2025/8735