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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gamze Bozkul
- Número de telefone: +903246000033
- E-mail: gamze.bozkul@gmail.com
Estude backup de contato
- Nome: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Locais de estudo
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Mersin, Turquia (Türkiye), 33400
- Tarsus University
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Contato:
- GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ansiedade
Prazo: 10 meses
|
Escala de Ansiedade Estado: Neste estudo foi utilizado o DAQ, que é estruturado para medir sentimentos momentâneos.
A sua validade e fiabilidade turca foram conduzidas por Öner e Le Compte em 1983.
O DAQ consiste em 20 questões em uma escala Likert de quatro pontos.
As afirmações do DAQ são avaliadas como nada (1), pouco (2), muito (3) e completamente (4).
Nesta seção, as declarações são divididas em declarações diretas e invertidas.
Declarações invertidas: 1º, 2º, 5º, 5º, 8º, 8º, 10º, 11º, 15º, 16º, 19º, 20º itens.
A pontuação total das afirmações invertidas é subtraída da pontuação total das afirmações diretas e o número 50, que é o valor invariante do DAQ, é adicionado ao valor obtido e a pontuação do DAQ é calculada.
A pontuação da escala varia entre 20-80 e um aumento na pontuação indica um aumento no nível de ansiedade.
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10 meses
|
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Procedure-related Fear
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comfort
Prazo: 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.
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10 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Gamze Bozkul, Tarsus University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TU-BOZKUL-020
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