The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction

January 26, 2023 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University

The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied Coronary Angiography

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Güneydoğu Anadolu Bölgesi
      • Istanbul, Güneydoğu Anadolu Bölgesi, Turkey, 21076
        • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Routine maintenance will be applied
Experimental: 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).
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Before angiography (mean 6 months after study completion)
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)
Visual Analog Scale
Time Frame: After angiography (through study completion, an average of 6 month)
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)
Anxiety Assessment Scale
Time Frame: Before angiography (mean 6 months after study completion)
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)
Anxiety Assessment Scale
Time Frame: After angiography (through study completion, an average of 6 month)
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)
Physiological Symptoms of Anxiety Follow-up Form
Time Frame: Before angiography (mean 6 months after study completion)
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)
Physiological Symptoms of Anxiety Follow-up Form
Time Frame: After angiography (through study completion, an average of 6 month)
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)
Virtual Reality Glasses Application Satisfaction Form
Time Frame: Before angiography (mean 6 months after study completion)
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)
Virtual Reality Glasses Application Satisfaction Form
Time Frame: After angiography (through study completion, an average of 6 month)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Sabahattin Zaim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6811

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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