- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07117838
- Original Trial
Vırtual Reality and Music in Coronary Angiography
Distractional Interventions on Patients' Anxiety, Pain and Physiological Parameters Durıng Coronary Angiography: The Effect of Virtual Reality and Music
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Before starting the application, patients who meet the criteria for inclusion in the study will be determined according to the randomization order and information about the study will be given.
Patients will be randomly assigned to the control and intervention groups (virtual reality and music group). Then, the following interventions will be applied sequentially, depending on the group the patient is included in.
After the appropriate participants are determined, written informed consent will be given to the participants and the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied just before the procedure begins, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form. Later patients will undergo coronary angiography. For the control group, conventional procedures will be applied by the researcher and medical care staff.
Patients in the virtual reality group, one of the intervention groups, will be shown a video with predetermined relaxing visuals and sounds through virtual reality glasses. Before watching the video, the researcher informed about the use of virtual reality glasses.
The patient will be informed. They will use the SG glasses for 3-5 minutes before the procedure begins for the patient to get used to it, and then the procedure will begin. VR glasses will be kept on throughout the procedure. In addition, the patient is advised at any stage of the application.
He will be told that he can remove his glasses and withdraw from the study. USB MP3 players and headphones will be provided by the researcher to collect data for the music group. Various styles of music (Classical World Music, Popular Music, Classical Turkish Music, Sufi Music) will be loaded into the USB MP3 player. Patients will be able to choose any of these music styles from the folder and listen to them. Music group patients from the intervention groups will be informed before starting the procedure and will be given 3-5 minutes.
MP3 reader and headphones will be provided throughout. Then, the patient will be taken to the coronary angiography procedure and will be allowed to listen to the previously prepared music of the patient's choice throughout the procedure.
Physiological parameters of patients during coronary angiography will be measured. After the procedure is completed, the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied to the patients in all three groups, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
tuşba
-
Van, tuşba, Turkey (Türkiye), 65100
- Van Yuzuncu Yil University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Between the ages of 18-70, Patients who agreed to participate in the study voluntarily, Open to communication, Knows how to read and write, Patients without visual or auditory impairments, Patients who underwent femoral artery area intervention, Patients who are administered opioid and tranquilizer derivative drugs, Patients who were undergoing coronary angiography for the first time were included in the study.
Exclusion Criteria:
Having difficulty using virtual reality glasses, Patients with headache, nausea and vomiting were not included in the study.
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
Patients were fitted with virtual reality glasses.
|
Virtual reality application were applied to patients during coronary angiography.
|
|
Experimental: music
Patients were listened to music
|
Patients will listen to music during coronary angiography.
|
|
No Intervention: control
Patients were not interfered with and were receive standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Identification Form
Time Frame: 10 minutes
|
This form, prepared by researchers based on literature reviews, consists of a total of 13 questions to question the socio-demographic characteristics of patients and their disease-related characteristics.
|
10 minutes
|
|
Visual Analog Scale
Time Frame: 10 minutes
|
The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences.
The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales.
To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain."
The scale can be applied horizontally or vertically.
The point marked by the patient is used as numerical data to determine the level of pain perception.
On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.
|
10 minutes
|
|
State Anxiety Scale
Time Frame: 10 minutes
|
The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Oner and Le Compte (1998).
The scale consists of a total of 40 items and two separate scales.
The first section includes the "State Anxiety Scale," which measures how a person feels in a given moment.
The second section includes the "Trait Anxiety Scale," which also includes statements about how a person generally feels.
This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on literature research and expert opinions.
|
10 minutes
|
|
Patient Follow-up Form
Time Frame: 10 minutes
|
This is a form created by researchers to record the physiological parameters (heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation) measured by researchers before (manually), during (digitally via a femoral catheter), and after the procedure (digitally via a femoral catheter).
The measurements taken from the patient were recorded on this form.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Harun ÜNAL, phd student, Ataturk Universty
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
- 1476
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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