- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06458647
The Effect of Video Streaming With Virtual Reality Before Coronary Angiography
June 9, 2024 updated by: Sevda Korkut, TC Erciyes University
The Effect of Video Streaming With Virtual Reality on Anxiety, Comfort and Patient Satisfaction Before Coronary Angiography
This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography.
Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography.
Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.
In addition to the standard practices of the clinic, individuals in the intervention group will be shown a video with virtual reality glasses before entering the angiography procedure.
Only standard practices of the clinic will be applied to the control group.
Study Type
Interventional
Enrollment (Estimated)
74
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Can speak and understand Turkish,
- Over 18 years of age,
- No previous angiography procedure,
- Oriented to place and time,
- No psychiatric illness,
- Not taking any sedative medication,
- No vision and hearing problems,
- Patients who volunteered to participate in the study will be included.
Exclusion Criteria:
- Patients with any pain or chronic pain prior to coronary angiography,
- Patients diagnosed with anxiety,
- Patients with pacemakers,
- Patients requiring emergency angiography,
- Patients taking antihistamines and psychiatric drugs,
- Patients who did not volunteer to participate in the study,
- Patients taking tranquilizers or pain medication up to 5 hours before the angiography procedure were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Intervention group
Individuals in the intervention group will be shown a video with virtual reality glasses before entering the angiography procedure.
|
In the study, patients in the intervention group will be watched videos of natural landscapes such as mountains, beaches and waterfalls with virtual reality goggles before the angiography procedure.
|
|
No Intervention: Control group
No application will be made to the control group before the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: 30 minutes after angiography
|
This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings.
The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days.
|
30 minutes after angiography
|
|
Comfort
Time Frame: 30 minutes after angiography
|
The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences.
|
30 minutes after angiography
|
|
Patient satisfaction
Time Frame: 30 minutes after angiography
|
Patients will be asked to rate their satisfaction with the intervention on a 10-point scale.
|
30 minutes after angiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
October 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
June 9, 2024
First Submitted That Met QC Criteria
June 9, 2024
First Posted (Actual)
June 13, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 9, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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