- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Gamze Bozkul
- Telefonnummer: +903246000033
- E-Mail: gamze.bozkul@gmail.com
Studieren Sie die Kontaktsicherung
- Name: GAMZE BOZKUL
- E-Mail: gamze.bozkul@gmail.com
Studienorte
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Mersin, Türkei (türkiye), 33400
- Tarsus University
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Kontakt:
- GAMZE BOZKUL
- E-Mail: gamze.bozkul@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Angst
Zeitfenster: 10 Monate
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Die State Anxiety Scale: In dieser Studie wurde der DAQ verwendet, der zur Messung momentaner Gefühle konzipiert ist.
Seine türkische Gültigkeit und Zuverlässigkeit wurde 1983 von Öner und Le Compte durchgeführt.
Der DAQ besteht aus 20 Fragen auf einer vierstufigen Likert-Skala.
Die Aussagen im DAQ werden mit gar nicht (1), wenig (2), sehr (3) und völlig (4) bewertet.
In diesem Abschnitt werden die Aussagen in direkte und umgekehrte Aussagen unterteilt.
Invertierte Aussagen: 1., 2., 5., 5., 8., 8., 10., 11., 15., 16., 19., 20. Item.
Die Gesamtpunktzahl der umgekehrten Aussagen wird von der Gesamtpunktzahl der direkten Aussagen abgezogen und die Zahl 50, die der invariante Wert des DAQ ist, zum erhaltenen Wert addiert und die DAQ-Punktzahl berechnet.
Der Skalenwert liegt zwischen 20 und 80 und ein Anstieg des Punktes deutet auf eine Zunahme des Angstniveaus hin.
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10 Monate
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Procedure-related Fear
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Comfort
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Gamze Bozkul, Tarsus University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TU-BOZKUL-020
Plan für individuelle Teilnehmerdaten (IPD)
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