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Completed

NCT Number: NCT07087990

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

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.

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Key information

Conditions

Coronary Angiography (CAG) Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Sabattin Zaim Üniversitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • None

Treatment and study plan

Virtual Reality Glasses

Device

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

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.

Primary outcomes

  1. Change in State Anxiety Inventory (SAI) Scores

    Time frame: Before and immediately after coronary angiography procedure

    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.

Secondary outcomes

  1. Change in Anxiety Visual Analogue Scale (VAS) Scores

    Time frame: Before and immediately after coronary angiography procedure

    Patients' anxiety levels will be assessed before and after coronary angiography using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no anxiety and 10 indicates extreme anxiety.

  2. Change in Pain Visual Analogue Scale (VAS) Scores

    Time frame: Before and immediately after coronary angiography procedure

    Patients' pain levels will be evaluated before and after coronary angiography using a 10 cm Visual Analogue Scale (VAS), where 0 means no pain and 10 indicates worst possible pain.

Other outcomes

  1. Satisfaction with Virtual Reality Glasses Application

    Time frame: Immediately after virtual reality glasses intervention

    Patient satisfaction will be assessed using a 4-item custom form developed specifically for this study. The first item uses a 0 to 10 Visual Analogue Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "extremely satisfied". The remaining items assess patient preferences and recommendations using multiple-choice questions (yes/no/undecided). Higher VAS scores reflect greater satisfaction.

  2. Satisfaction with Stress Ball Application

    Time frame: Immediately after stress ball intervention

    Patient satisfaction will be evaluated using a 4-item form developed for this study. The first item uses a 0 to 10 Visual Analogue Scale (VAS), where 0 indicates no satisfaction and 10 indicates the highest satisfaction. The remaining three items gather feedback through multiple-choice responses. Higher VAS scores indicate greater satisfaction.

Sponsors and collaborators

Lead sponsor

Istanbul Sabahattin Zaim University

Other

Registry information

Official study title

The Effect of Virtual Reality Glasses and Stress Ball on Anxiety, Pain, and Satisfaction in Patients Undergoing Coronary Angiography: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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