Effect of VR Glasses and Stress Ball on Anxiety in Coronary Angiography Patients

NCT07087990 | Completed

• 1 other identifier: IZU-EC-2024-10
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.

Conditions

Coronary Angiography (CAG); Anxiety; Pain

Keywords

Coronary Angiography; Virtual Reality; Stress Balls; Anxiety; pain; Satisfaction Levels

Outcome Measures

Primary Outcomes (1)

• Change in State Anxiety Inventory (SAI) Scores

  the study will measure changes in situational anxiety levels of patients undergoing coronary angiography, using the State Anxiety Inventory (SAI) before and after the procedure with virtual reality glasses and stress balls. The SAI consists of 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80; higher scores indicate higher anxiety.

  Before and immediately after coronary angiography procedure

Secondary Outcomes (2)

• Change in Anxiety Visual Analogue Scale (VAS) Scores

  Before and immediately after coronary angiography procedure

• Change in Pain Visual Analogue Scale (VAS) Scores

  Before and immediately after coronary angiography procedure

Other Outcomes (2)

• Satisfaction with Virtual Reality Glasses Application

  Immediately after virtual reality glasses intervention

• Satisfaction with Stress Ball Application

  Immediately after stress ball intervention

Study Arms (3)

VR Group"Participants in this group were provided with virtual reality glasses during coronary angio

EXPERIMENTAL

Participants in this group were provided with virtual reality glasses during coronary angiography to assess the effect on anxiety, pain, and satisfaction.

Device: Virtual Reality Glasses

Stress Ball Group

EXPERIMENTAL

Participants in this group used a stress ball during coronary angiography to evaluate its effect on anxiety, pain, and satisfaction.

Other: Stress Ball

Control Group

NO INTERVENTION

Participants in this group received standard care during coronary angiography without the use of virtual reality glasses or stress ball. Anxiety, pain, and satisfaction levels were assessed

Interventions

Virtual Reality Glasses DEVICE

articipants in the VR group used virtual reality glasses during coronary angiography to reduce anxiety and pain and improve satisfaction.

VR Group"Participants in this group were provided with virtual reality glasses during coronary angio

Stress Ball OTHER

articipants in the stress ball group used a stress ball during coronary angiography to evaluate its effects on anxiety, pain, and satisfaction.

Stress Ball Group

Eligibility Criteria

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

You may qualify if:

• Voluntary participation in the study
• Age 18 years or older
• Undergoing coronary angiography for the first time
• Cognitive ability to answer the questions
• No diagnosis of anxiety disorder and no use of medication for anxiety / no psychiatric diagnosis
• No physical disability preventing the use of the stress ball
• No problems with vision, hearing, or understanding

You may not qualify if:

• None

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabattin Zaim Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zülfünaz Özer, PhD

  İstanbul Sabahattin Zaim University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomize kontrollü

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 28, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)