- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Gamze Bozkul
- Numero di telefono: +903246000033
- Email: gamze.bozkul@gmail.com
Backup dei contatti dello studio
- Nome: GAMZE BOZKUL
- Email: gamze.bozkul@gmail.com
Luoghi di studio
-
-
-
Mersin, Turchia (Türkiye), 33400
- Tarsus University
-
Contatto:
- GAMZE BOZKUL
- Email: gamze.bozkul@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Nessun intervento: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Ansia
Lasso di tempo: 10 mesi
|
La scala dell'ansia di stato: in questo studio è stata utilizzata la DAQ, strutturata per misurare i sentimenti momentanei.
La sua validità e affidabilità turca è stata condotta da Öner e Le Compte nel 1983.
Il DAQ è composto da 20 domande su una scala Likert a quattro punti.
Le affermazioni nel DAQ vengono valutate come per niente (1), poco (2), molto (3) e completamente (4).
In questa sezione le affermazioni sono divise in affermazioni dirette e inverse.
Affermazioni invertite: 1°, 2°, 5°, 5°, 8°, 8°, 10°, 11°, 15°, 16°, 19°, 20° elemento.
Il punteggio totale delle affermazioni invertite viene sottratto dal punteggio totale delle affermazioni dirette e al valore ottenuto viene aggiunto il numero 50, che è il valore invariante del DAQ, e viene calcolato il punteggio DAQ.
Il punteggio della scala varia tra 20 e 80 e un aumento del punteggio indica un aumento del livello di ansia.
|
10 mesi
|
|
Procedure-related Fear
Lasso di tempo: 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
Lasso di tempo: 10 months
|
It is a form used to record patients' Physiological Parameters before and after the procedure.
|
10 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Comfort
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Gamze Bozkul, Tarsus University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TU-BOZKUL-020
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .