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

23. Juli 2026 aktualisiert von: Gamze BOZKUL, Tarsus University

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

Noch keine Rekrutierung

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

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

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

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Angst
Zeitfenster: 10 Monate
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.
10 Monate
Procedure-related Fear
Zeitfenster: 10 months
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.
10 months
Physiological Parameters
Zeitfenster: 10 months
It is a form used to record patients' Physiological Parameters before and after the procedure.
10 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Comfort
Zeitfenster: 10 months
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.
10 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Gamze Bozkul, Tarsus University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

20. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TU-BOZKUL-020

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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