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Clinical Trials/NCT07087990
NCT07087990CompletedNot Applicable

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

Istanbul Sabahattin Zaim University1 site in 1 country105 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
105
Locations
1
Primary Endpoint
Change in State Anxiety Inventory (SAI) Scores

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

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.

Intervention: Virtual Reality Glasses (Device)

Stress Ball Group

Experimental

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

Intervention: Stress Ball (Other)

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

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Istanbul Sabahattin Zaim University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rabia Ozdemir

Principal Investigator

Istanbul Sabahattin Zaim University

Study Sites (1)

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