Effect of Stress Ball Application During Coronary Angiography on Anxiety, Procedure-related Fear, Physiological Parameters, and Comfort

Официальное название

Effect of Stress Ball Application During Coronary Angiography on Anxiety, Procedure-related Fear, Physiological Parameters, and Comfort: a Randomized Controlled Trial

Обзор

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.

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.

Вмешательства

• Другое Stress ball
  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.

Первичные конечные точки

• Anxiety [Срок оценки: 10 months]
• Procedure-related Fear [Срок оценки: 10 months]
• Physiological Parameters [Срок оценки: 10 months]

Вторичные конечные точки (1)

• Comfort [Срок оценки: 10 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Четверное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Tarsus University — Mersin

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. PMID 41432646
• 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. PMID 38520118
• 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. PMID 40337440
• 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. PMID 40411390
• 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. PMID 41457207

Идентификаторы

NCT: NCT07723521 · TU-BOZKUL-020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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