- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07723521
Effect of Stress Ball Application During Coronary Angiography on Anxiety, Procedure-related Fear, Physiological Parameters, and Comfort
Effect of Stress Ball Application During Coronary Angiography on Anxiety, Procedure-related Fear, Physiological Parameters, and Comfort: a Randomized Controlled Trial
The aim of this study is to investigate the effect of stress ball application during coronary angiography on anxiety, procedure-related fear, physiological parameters, and comfort. The study is designed as a prospective, randomized controlled clinical trial. The study population will consist of patients scheduled to undergo coronary angiography at Tarsus State Hospital. The sample size was calculated based on the post-test anxiety score effect size (Cohen's d = 0.43) reported in the study by Yüksel and Güneş (2024), which examined the effect of stress ball application on anxiety and pain levels during angiography procedures. Using a significance level of α = 0.05 and a statistical power of 90% (1-β = 0.90), the required sample size was calculated as 59 participants. To account for potential attrition, the sample size was increased by 10%, resulting in a final sample of 64 participants (intervention group: n = 32; control group: n = 32). Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form. Upon admission to the coronary angiography unit and before the procedure, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, and Physiological Parameters Monitoring Form. These assessments will be administered by researcher NÇ.
In addition to routine care, patients in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the angiography procedure. Researcher GB will be responsible for implementing the intervention.
Patients in the control group will receive only the unit's standard care. Routine care includes pre-procedural patient education, assessment of vital signs, verification of intravenous line patency, preparation of the vascular access site, and standard patient monitoring throughout the procedure. Care will be provided according to the standard care protocol routinely implemented in the hospital's coronary angiography unit.
Immediately after the procedure, the State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form will be administered by researcher NÇ.
Обзор исследования
Подробное описание
The aim of this study is to investigate the effect of stress ball application during coronary angiography on anxiety, procedure-related fear, physiological parameters, and comfort. The study is designed as a prospective, randomized controlled clinical trial. The study population will consist of patients scheduled to undergo coronary angiography at Tarsus State Hospital. The sample size was calculated based on the post-test anxiety score effect size (Cohen's d = 0.43) reported in the study by Yüksel and Güneş (2024), which examined the effect of stress ball application on anxiety and pain levels during angiography procedures. Using a significance level of α = 0.05 and a statistical power of 90% (1-β = 0.90), the required sample size was calculated as 59 participants. To account for potential attrition, the sample size was increased by 10%, resulting in a final sample of 64 participants (intervention group: n = 32; control group: n = 32). Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form. Upon admission to the coronary angiography unit and before the procedure, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, and Physiological Parameters Monitoring Form. These assessments will be administered by researcher NÇ.
In addition to routine care, patients in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the angiography procedure. Researcher GB will be responsible for implementing the intervention.
Patients in the control group will receive only the unit's standard care. Routine care includes pre-procedural patient education, assessment of vital signs, verification of intravenous line patency, preparation of the vascular access site, and standard patient monitoring throughout the procedure. Care will be provided according to the standard care protocol routinely implemented in the hospital's coronary angiography unit.
Immediately after the procedure, the State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form will be administered by researcher NÇ.
To ensure researcher safety during data collection, all procedures will be conducted in accordance with clinical workplace regulations. Researchers will comply with hospital infection prevention and control measures and will use appropriate personal protective equipment whenever necessary. As data collection will take place in the coronary angiography unit, researchers will also adhere to radiation safety regulations by minimizing their presence within the fluoroscopy field during the procedure and using lead aprons and other radiation-protective equipment whenever required. Furthermore, all data collection activities will be performed in accordance with the institution's occupational health and safety procedures.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Gamze Bozkul
- Номер телефона: +903246000033
- Электронная почта: gamze.bozkul@gmail.com
Учебное резервное копирование контактов
- Имя: GAMZE BOZKUL
- Электронная почта: gamze.bozkul@gmail.com
Места учебы
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Mersin, Турция (Туркие), 33400
- Tarsus University
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Контакт:
- GAMZE BOZKUL
- Электронная почта: gamze.bozkul@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Aged 18 years or older, as verified by medical records and official identification.
- Scheduled to undergo elective coronary angiography, as confirmed by the patient's medical records.
- Conscious, oriented, and cooperative, as assessed by the researcher during the pre-procedural interview.
- Able and willing to provide written informed consent after receiving information about the study.
- Able to speak Turkish and understand and respond to the questions asked during the study.
- No visual, hearing, or speech impairment that would interfere with communication.
- No motor or sensory impairment of the hand or arm that would prevent the use of a stress ball, as assessed through patient self-report and clinical observation.
- No diagnosed anxiety disorder and no self-reported history of receiving psychiatric treatment for anxiety.
Exclusion Criteria:
- Decline to participate or request to withdraw from the study at any stage.
- Undergo emergency coronary angiography.
- Have cognitive, communication, or physical impairments that prevent completion of the data collection instruments or participation in the study procedures.
- Develop clinical complications during or after the procedure that preclude implementation of the study protocol.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Experimental group
In addition to routine care, participants in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the procedure.
Researcher GB will be responsible for administering the intervention.
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participants in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the procedure.
Researcher GB will be responsible for administering the intervention.
|
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Без вмешательства: Control group
Participants in the control group will receive the unit's standard care only.
As part of routine care, patients will receive pre-procedural education.
Before the procedure, vital signs will be assessed, intravenous line patency will be verified, and the vascular access site will be prepared.
Standard patient monitoring will be maintained throughout the procedure.
All care will be provided in accordance with the standard care protocol routinely implemented in the institution's coronary angiography unit.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Беспокойство
Временное ограничение: 10 месяцев
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Шкала государственной тревоги. В этом исследовании использовался DAQ, структурированный для измерения сиюминутных чувств.
Его валидность и надежность на турецком языке были проверены Онером и Ле Компте в 1983 году.
DAQ состоит из 20 вопросов по четырехбалльной шкале Лайкерта.
Заявления в DAQ оцениваются как совсем нет (1), немного (2), много (3) и полностью (4).
В этом разделе утверждения делятся на прямые и обратные утверждения.
Перевернутые утверждения: 1-е, 2-е, 5-е, 5-е, 8-е, 8-е, 10-е, 11-е, 15-е, 16-е, 19-е, 20-е пункты.
Общая оценка перевернутых операторов вычитается из общей оценки прямых операторов, а число 50, которое является инвариантным значением DAQ, добавляется к полученному значению и рассчитывается оценка DAQ.
Оценка по шкале колеблется от 20 до 80, и увеличение балла указывает на повышение уровня тревоги.
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10 месяцев
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Procedure-related Fear
Временное ограничение: 10 months
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Patients' fear will be assessed using a visual analog scale (VAS) ranging from 0 to 10; 0 represents "No fear at all," and 10 represents "Maximum fear."
The minimum possible score is 0, and the maximum score is 10.
Higher total scores indicate a higher level of fear experienced by the patient during or prior to the procedure.
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10 months
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Physiological Parameters
Временное ограничение: 10 months
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It is a form used to record patients' Physiological Parameters before and after the procedure.
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10 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Comfort
Временное ограничение: 10 months
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Patients will assess their comfort using a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10 (Wewers & Lowe, 1990).
A score of 0 indicates "Not comfortable at all," whereas a score of 10 indicates "Extremely comfortable."
The total score ranges from 0 to 10, with higher scores indicating greater perceived comfort.
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10 months
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Gamze Bozkul, Tarsus University
Публикации и полезные ссылки
Общие публикации
- Ucar O, Kas S. The Effect of Stress Ball Use on Pain and Anxiety in Day Surgery. J Perianesth Nurs. 2026 Jun;41(3):630-637. doi: 10.1016/j.jopan.2025.08.018. Epub 2025 Dec 23.
- Mendes FCO, Santos KVGD, Dantas JKDS, Araujo SCM, Teixeira FC, Leal KCDS, Dantas DV, Dantas RAN. Non-pharmacological strategies to reduce stress and anxiety in endovascular procedures: A scoping review. Nurs Open. 2024 Mar;11(3):e2105. doi: 10.1002/nop2.2105.
- Tran H, Nguyen DM, Le NQ, Nguyen TM, Tran KD. Factors associated with perioperative anxiety among patients undergoing coronary angiography or angioplasty: a cross-sectional study. Ann Med Surg (Lond). 2025 Apr 4;87(5):2668-2673. doi: 10.1097/MS9.0000000000003265. eCollection 2025 May.
- Kadayif A, Cengiz Acil H. Perceived stress and anxiety levels of patients undergoing coronary angiography. J Int Med Res. 2025 May;53(5):3000605251340168. doi: 10.1177/03000605251340168. Epub 2025 May 24.
- Palandacic AK, Ucman S, Kovacic D, Sarotar BN, Lainscak M. Anxiety in patients referred for elective coronary angiography: a prospective cohort study. BMC Cardiovasc Disord. 2025 Dec 29;26(1):96. doi: 10.1186/s12872-025-05454-5.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- TU-BOZKUL-020
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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