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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05459246
Other study ID # 6811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 4, 2022
Est. completion date November 29, 2022

Study information

Verified date January 2023
Source Istanbul Sabahattin Zaim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied Angiography.


Description:

Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30-45 minutes).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 29, 2022
Est. primary completion date September 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Being over 18 years old - Ability to communicate adequately - Absence of psychiatric problems - Volunteering to participate in the research - Experiencing coronary angiography for the first time Exclusion Criteria: - Those who have communication problems - Those with psychiatric problems - Emergency coronary angiography - Having symptoms of myocardial infarction, - Being unconscious, - Having surgery in the last 6 weeks,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality glasses
Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30-45 minutes).

Locations

Country Name City State
Turkey Istanbul Sabahattin Zaim University, Faculty of Health Sciences Istanbul Güneydogu Anadolu Bölgesi

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm. Before angiography (mean 6 months after study completion)
Primary Visual Analog Scale The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm. After angiography (through study completion, an average of 6 month)
Primary Anxiety Assessment Scale Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety. Before angiography (mean 6 months after study completion)
Primary Anxiety Assessment Scale Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety. After angiography (through study completion, an average of 6 month)
Primary Physiological Symptoms of Anxiety Follow-up Form This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value. Before angiography (mean 6 months after study completion)
Primary Physiological Symptoms of Anxiety Follow-up Form This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value. After angiography (through study completion, an average of 6 month)
Primary Virtual Reality Glasses Application Satisfaction Form In this form, there are questions prepared in line with the relevant literature in order to determine the satisfaction with the video watched with virtual reality glasses. Before angiography (mean 6 months after study completion)
Primary Virtual Reality Glasses Application Satisfaction Form In this form, there are questions prepared in line with the relevant literature in order to determine the satisfaction with the video watched with virtual reality glasses. After angiography (through study completion, an average of 6 month)
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