Effect of Virtual Reality Glasses on Stress, Muscle Tension, and Physiological Parameters Before Angiography

NCT ID: NCT06969885

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-30

Brief Summary

Today, cardiovascular diseases are the leading cause of morbidity and mortality worldwide. Coronary angiography (CAG), a commonly used invasive procedure for diagnosing coronary artery disease, may trigger fear, stress, and anxiety in patients due to its invasive nature, lack of information, uncertainty, and the possibility of receiving a life-threatening diagnosis.These emotional responses activate stress mechanisms, leading to catecholamine release, increased heart rate, blood pressure, respiration, sweating, and muscle tension. Elevated stress can also cause lactic acid accumulation, increased oxygen demand, and muscular contraction, potentially resulting in coronary artery spasms or arrhythmias, and increasing procedural risks. Therefore, reducing stress before CAG is crucial to improving procedural outcomes and patient recovery.

To address preoperative anxiety and stress, both pharmacologic and non-pharmacologic interventions are used. Among the non-pharmacologic options, virtual reality (VR) has emerged as an effective method to distract and calm patients, reducing anxiety, stress, and pain. Studies in various patient populations suggest VR glasses can be beneficial in managing psychological distress. However, no study has been found in the literature evaluating the effect of VR on stress-induced muscle tension in patients undergoing CAG. This gap highlights the potential contribution of this study to current knowledge.

This study aims to investigate the effect of using VR glasses before coronary angiography on patients' stress levels, muscle tension, and selected physiological parameters.

Detailed Description

Study Hypotheses:

H0: There is no difference in preoperative stress, muscle tension, or physiological parameters.

H1: There is a difference in preoperative stress levels. H2: There is a difference in preoperative muscle tension. H3: There is a difference in certain physiological parameters preoperatively. H4: There is a relationship between stress, muscle tension, and physiological parameters preoperatively.

Conditions

Coronary Angiography (CAG)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

No intervention will be made to the patients outside of the hospital routine, and approximately 10 minutes before the procedure, the Physiological Parameters Monitoring Form, Distress Thermometer and VAS will be applied again and the data collection process will be completed.

Group Type: OTHER

Standard application

Intervention Type: BEHAVIORAL

No intervention will be made to the patients outside of the hospital routine, and approximately 10 minutes before the procedure, the Physiological Parameters Monitoring Form, Distress Thermometer and VAS will be applied again and the data collection process will be completed.

Experimental Group

In the preoperative period, approximately 1 hour before the procedure, a video will be watched for 15 minutes with virtual reality glasses. Approximately 10 minutes before the procedure, the patients will be administered the Physiological Parameters Monitoring Form, Distress Thermometer and VAS, and the data collection process will be completed.

Group Type: EXPERIMENTAL

Intervention application with virtual reality glasses

Intervention Type: BEHAVIORAL

In the preoperative period, approximately 1 hour before the procedure, a video will be watched for 15 minutes with virtual reality glasses. Approximately 10 minutes before the procedure, the patients will be administered the Physiological Parameters Monitoring Form, Distress Thermometer and VAS, and the data collection process will be completed.

Interventions

Intervention application with virtual reality glasses

In the preoperative period, approximately 1 hour before the procedure, a video will be watched for 15 minutes with virtual reality glasses. Approximately 10 minutes before the procedure, the patients will be administered the Physiological Parameters Monitoring Form, Distress Thermometer and VAS, and the data collection process will be completed.

Intervention Type: BEHAVIORAL

Standard application

No intervention will be made to the patients outside of the hospital routine, and approximately 10 minutes before the procedure, the Physiological Parameters Monitoring Form, Distress Thermometer and VAS will be applied again and the data collection process will be completed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Scheduled to undergo CAG,
• American Society of Anesthesiologists (ASA) score I or II,
• Turkish-speaking patients will be included.

Exclusion Criteria

• with dizziness,
• with headache,
• with any known psychiatric disease and mental perception problem,
• pregnant,
• with a history of epilepsy,
• with vision, hearing and perception problems,
• with closed space phobia,
• with a history of dizziness, nausea, etc. due to previous virtual reality use will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuksek Ihtisas University

OTHER

Sponsor Role: lead

Responsible Party

Aylin GÜÇLÜ DEMİREL

Assistant Professor (PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yüksek İhtisas University

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Aylin GÜÇLÜ DEMİREL Assistant Professor (PhD), PhD

Role: CONTACT

aylinguclu11@gmail.com

+90 5064384935

Other Identifiers

2024/215

Identifier Type: -

Identifier Source: org_study_id