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

23. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Angst
Tidsramme: 10 måneder
The State Anxiety Scale: I denne undersøgelse blev DAQ, som er struktureret til at måle øjeblikkelige følelser, brugt. Dens tyrkiske gyldighed og pålidelighed blev udført af Öner og Le Compte i 1983. DAQ'en består af 20 spørgsmål på en firepunkts Likert-skala. Udsagnene i DAQ vurderes som slet ikke (1), lidt (2), meget (3) og fuldstændig (4). I dette afsnit er udsagnene opdelt i direkte og omvendte udsagn. Omvendte udsagn: 1., 2., 5., 5., 8., 8., 10., 11., 15., 16., 19., 20. punkter. Den samlede score for de omvendte udsagn trækkes fra den samlede score for de direkte udsagn, og tallet 50, som er den invariante værdi af DAQ'en, lægges til den opnåede værdi, og DAQ-scoren beregnes. Skalaens score går mellem 20-80, og en stigning i scoren indikerer en stigning i niveauet af angst.
10 måneder
Procedure-related Fear
Tidsramme: 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
Tidsramme: 10 months
It is a form used to record patients' Physiological Parameters before and after the procedure.
10 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comfort
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Gamze Bozkul, Tarsus University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TU-BOZKUL-020

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