- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07032935
- Original Trial
The Effect of Virtual Reality Glasses on Vital Signs and State Anxiety in Patients Undergoing Coronary Angiography
Virtual reality (VR) glasses are an effective non-pharmacological method for reducing anxiety, supported by a high level of evidence and associated with no known side effects. Techniques involving relaxation and distraction, such as VR, function by suppressing the sympathetic branch of the autonomic nervous system and activating the parasympathetic branch, thereby eliciting a relaxation response.
VR glasses divert the patient's attention away from pain and anxiety. By reducing the sense of unfamiliarity in clinical environments, VR helps patients adapt more easily, leading to enhanced relaxation. This state of relaxation not only alleviates anxiety but also induces favorable physiological responses. These include reductions in blood pressure (BP), heart rate (HR), and respiratory rate (RR), along with an increase in peripheral oxygen saturation (SpO₂). Additionally, the psychological benefits of VR contribute to the reduction of anxiety, stress, fear, and worry.
VR is considered a cost-effective, safe, and non-pharmacological intervention. Several studies support its efficacy. For example, in a study comparing the effects of video games played through VR headsets and iPads on preoperative anxiety in adult patients undergoing sternotomy, anxiety was measured using the Depression Anxiety Stress Scale (DASS), and lower anxiety levels were observed in the VR group. Another study demonstrated that watching nature scenes through VR glasses for five minutes prior to maxillofacial surgery significantly reduced anxiety. Furthermore, research comparing progressive muscle relaxation exercises and VR during arthroscopic knee surgery-measured using the State Anxiety Inventory-indicated that both non-pharmacological interventions were effective in reducing anxiety.
However, despite this growing body of evidence, no study to date has examined the effects of VR applications on anxiety in patients undergoing coronary angiography or pacemaker implantation. This study aims to fill that gap by investigating the comparative effectiveness of virtual reality applications in reducing anxiety in patients undergoing coronary angiography.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kütahya
-
Merkez, Kütahya, Turkey (Türkiye), 43200
- Kutahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Patients who will undergo coronary angiography or pacemaker implantation, Not to receive sedation during the procedure, Written and verbal acceptance to participate in the study,
- Are over 18 years of age,
- Do not have any psychiatric illness,
- Do not have any vision, hearing or perception problems,
- Are at least a primary school graduate,
- Do not have any disorder/disease affecting decision-making ability (dementia, psychological disorder, etc.)
- Volunteer to participate in the study,
- Are open to communication and cooperation.
Exclusion Criteria:
- Patients who receive sedation, patients who cannot communicate, patients with visual or hearing impairments, and individuals who do not agree to participate in the research will be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention will be made to the patient during the Coronary Angiography application.
|
|
|
Experimental: virtual reality glasses Group
|
Virtual Reality Glasses will be used DURING CORONARY ANGIOGRAPHY APPLICATION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in State Anxiety Score
Time Frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
Before and after the intervention (pre- and post-intervention) It will be measured using the State Anxiety Inventory (STAI-I).
The score varies between 20 and 80.
|
Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Vital Signs (Heart Rate)
Time Frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
To be measured before and after the virtual reality intervention
|
Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
|
Change in Vital Signs (Blood Pressure)
Time Frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
To be measured before and after the virtual reality intervention
|
Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
|
Change in Vital Signs (Respiratory Rate)
Time Frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
To be measured before and after the virtual reality intervention
|
Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KutahyaHSU20240106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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