The Effect of Using Virtual Reality Glasses During Coronary Angiography

NCT04521660 | Unknown DMC

• 1 other identifier: 20-94
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary angiography (CAG) is a diagnostic method used as the gold standard in the diagnosis of coronary artery disease (CAD), which is increasingly prevalent in developed and developing countries and is one of the leading causes of morbidity and mortality in the world. Although coronary angiography is one of the best diagnostic methods of CAD, it can cause psychological problems such as stress, fear, anxiety in patients; It also causes physical problems such as bleeding, hematom and pain. Pharmacological and non-pharmacological methods are used by nurses to solve problems of patients, to ensure their relaxation and to improve their quality of life. With the development of technology, virtual reality (VR) glasses have been used to have fun at first, and later to provide pain management and to solve anxiety problems. VR glasses are an advanced technology that allows the patient to move into a virtual world and focus his attention on other thoughts, giving less attention to pain and anxiety. During literature search, no studies were found about the effect of using SG glasses on pain and anxiety during CAG. This research will be conducted to determine the effect of VR glasses used during CAG on pain, anxiety and hemodynamic parameters of patients who will experience coronary angiography for the first time.

Conditions

Coronary Angiography

Keywords

virtual reality; pain; anxiety; hemodynamic parameters; angiography

Outcome Measures

Primary Outcomes (1)

• Change on pain intensity as measured by Visual Analog Scale

  The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.

  'just before procedure and 30 minutes after procedure

Secondary Outcomes (1)

• Score change on anxiety level as measured by State-Trait Anxiety Inventory

  just before procedure and 30 minutes after procedure

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will wear virtual reality glasses during coronary angiography.

Device: Virtual reality glasses

Control group

NO INTERVENTION

Patients in the control group will not wear virtual reality glasses. They will be given standard care and treatment during the procedure.

Interventions

Virtual reality glasses DEVICE

Virtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety. In this study, VR glasses will be worn on the intervention group just before the procedure begins and patients will continue to wear their glasses until the procedure is completed.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older
• To experience coronary angiography for the first time
• Not having contraindications for coronary angiography
• Not having visual and hearing impairment
• To be orientation to place, time and person
• Not having mental deficiency
• Not being addicted to alcohol and drugs
• Not being diagnosed with a psychiatric illness
• Having agreed to participate in research

You may not qualify if:

• Having undergone a treatment procedure (stent, balloon, etc.) during coronary angiography
• Having had a radial coronary angiography
• Not wanting to participate in the study
• Have used any painkillers at least 5 hours before coronary angiography
• Making coronary angiography decision under emergency conditions

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Sağlık Bilimleri

Istanbul, 03445, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rabia Ermis

  Saglik Bilimleri University

  STUDY CHAIR

Central Study Contacts

Rabia Ermis

CONTACT

+90 (554) 988 54 43; rabiaermis35@gmail.com

Elif Gezginci, RN, PhD

CONTACT

elif.gezginci@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Asst Prof

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 20, 2020
• Study Start: November 20, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-02

Locations

TU (1)