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

NCT07723521 | Not Yet Recruiting

• 1 other identifier: TU-BOZKUL-020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Ball

Keywords

anxiety; procedure-related fear; physiological parameters; comfort

Outcome Measures

Primary Outcomes (3)

• Anxiety

  The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.

  10 months

• Procedure-related Fear

  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

  It is a form used to record patients' Physiological Parameters before and after the procedure.

  10 months

Secondary Outcomes (1)

• Comfort

  10 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Stress ball

Control group

NO INTERVENTION

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.

Interventions

Stress ball OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 41432646 BACKGROUND

• 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.

  PMID: 38520118 BACKGROUND

• 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.

  PMID: 40337440 BACKGROUND

• 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.

  PMID: 40411390 BACKGROUND

• 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.

  PMID: 41457207 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Gamze Bozkul

  Tarsus University

  STUDY DIRECTOR

Central Study Contacts

Gamze Bozkul

CONTACT

+903246000033; gamze.bozkul@gmail.com

GAMZE BOZKUL

CONTACT

gamze.bozkul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To minimize selection bias and ensure balanced group allocation, patients meeting the inclusion criteria will be assigned to either the stress ball intervention group or the control group according to computer-generated permuted block randomization sequences (e.g., ABBA, BABA) prepared by an independent biostatistician who is not involved in the study. After the allocation sequence has been generated, the correspondence between the allocation codes (A and B) and the study groups will be determined by a lottery. An external expert (academic nurse) (GCU), who will not otherwise participate in the study, will prepare sequentially numbered opaque sealed envelopes (numbered 1 to 64). Each envelope will contain the group assignment according to the predetermined randomization list. Patients presenting to the Coronary Angiography Unit will be assessed for eligibility. Those who meet the inclusion criteria, agree to participate, and provide written informed consent will be enrolled in the st
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study is designed as a prospective, randomized controlled clinical trial.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)