- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Gamze Bozkul
- Telefonní číslo: +903246000033
- E-mail: gamze.bozkul@gmail.com
Studijní záloha kontaktů
- Jméno: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Studijní místa
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Mersin, Turecko (Türkiye), 33400
- Tarsus University
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Kontakt:
- GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Úzkost
Časové okno: 10 měsíců
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Stupnice státní úzkosti: V této studii byla použita DAQ, která je strukturována tak, aby měřila momentální pocity.
Jeho tureckou platnost a spolehlivost provedli Öner a Le Compte v roce 1983.
DAQ se skládá z 20 otázek na čtyřbodové Likertově škále.
Výroky v DAQ jsou hodnoceny jako vůbec ne (1), málo (2), hodně (3) a úplně (4).
V této části jsou výpisy rozděleny na přímé a obrácené výpisy.
Převrácené výroky: 1., 2., 5., 5., 8., 8., 10., 11., 15., 16., 19., 20. položka.
Celkové skóre obrácených výroků se odečte od celkového skóre přímých výroků a k získané hodnotě se přičte číslo 50, což je invariantní hodnota DAQ, a vypočítá se skóre DAQ.
Skóre škály se pohybuje mezi 20-80 a zvýšení skóre ukazuje na zvýšení úrovně úzkosti.
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10 měsíců
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Procedure-related Fear
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Comfort
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Gamze Bozkul, Tarsus University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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