- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483619
Virtual Reality During Coronary Angiography: Effects on Pain and Anxiety (VR-CAPA)
Beyond the Cath Lab Curtain: Virtual Reality's Impact on Pain and Anxiety: A Randomized Controlled Trial
This study investigated whether virtual reality (VR) can reduce pain and anxiety in patients undergoing coronary angiography. Coronary angiography is a common cardiac procedure performed under local anesthesia while patients remain awake, which can cause significant pain and anxiety.
Adult patients scheduled for elective coronary angiography were randomly assigned to two groups: one group watched a nature-themed VR video during the procedure, while the control group received standard care. Pain and anxiety levels were measured before and after the procedure using validated scales.
The findings of this study may help healthcare providers offer a simple, non-pharmacological method to improve patient comfort during coronary angiography.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coronary angiography is one of the most frequently performed invasive cardiac diagnostic procedures. Although the procedure is performed under local anesthesia, patients remain conscious throughout, and procedural pain and anxiety are commonly reported. Non-pharmacological interventions to manage these symptoms are increasingly being explored as adjuncts to standard care.
Virtual reality (VR) is an immersive technology that engages the user's visual and auditory senses, potentially distracting patients from procedural discomfort. This randomized controlled trial examined the effect of VR on pain and anxiety in patients undergoing elective coronary angiography.
Patients were randomized into two groups using a sealed envelope method. The VR group watched a pre-selected nature-themed video through a VR headset throughout the procedure. The control group received standard care without any additional intervention. Pain was assessed using the Visual Analog Scale (VAS) and anxiety was measured using the State-Trait Anxiety Inventory (STAI) before and after the procedure.
The study was conducted at a cardiology unit in Istanbul, Turkey, and was approved by the institutional ethics committee (Approval No: 2019-84). Written informed consent was obtained from all participants prior to enrollment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Koc University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older
- Scheduled for elective coronary angiography
- Conscious and oriented
- Able to communicate verbally
- No prior coronary angiography experience
- Willing to participate and provided written informed consent
Exclusion Criteria:
- History of psychiatric disorder or use of psychiatric medication
- Visual or hearing impairment that would prevent VR use
- Hemodynamic instability
- Emergency coronary angiography
- Inability to complete the questionnaires
- Prior experience with virtual reality
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
Participants watched a nature-themed virtual reality video through a VR headset throughout the coronary angiography procedure in addition to standard care.
|
Participants in the VR group wore a virtual reality headset and watched a pre-selected nature-themed video throughout the coronary angiography procedure.
The VR intervention was applied in addition to standard care and was maintained for the entire duration of the procedure.
|
|
No Intervention: Control Group
Participants received standard care without any additional intervention during coronary angiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Measured before and immediately after the coronary angiography procedure
|
Pain was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Measured before and immediately after the coronary angiography procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Level Measured by State-Trait Anxiety Inventory (STAI-S)
Time Frame: Measured before and immediately after the coronary angiography procedure
|
Anxiety was assessed using the State-Trait Anxiety Inventory (STAI), which measures state anxiety (STAI-S) and trait anxiety (STAI-T).
State anxiety reflects current anxiety levels, while trait anxiety reflects general anxiety disposition.
Higher scores indicate greater anxiety.
|
Measured before and immediately after the coronary angiography procedure
|
Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-84
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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