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

NCT06969885 | Not Yet Recruiting

• 1 other identifier: 2024/215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Angiography (CAG)

Keywords

Coronary Angiography; Virtual Reality Glasses; Stress; Muscle Tension; Physiological Parameters

Outcome Measures

Primary Outcomes (6)

• Distress Thermometer

  It is a Likert-type scale with scores from 0 (no stress) to 10 (extreme stress) developed by Roth et al. (1998) to determine psychological distress in cancer patients. In the short and easy-to-understand scale, patients can easily mark their own stress levels within the specified ranges on the thermometer. The Turkish validity-reliability study of the Distress Thermometer was conducted by Özalp et al. (2007) . In their study, Özmen and Gürsoy (2021) concluded that the distress thermometer can be used as a valid and reliable measurement tool to measure the stress experienced by patients who will undergo surgery. With this scale, the stress levels of the patients in the last week and at the time of evaluation will be evaluated.

  Preoperative period

• Assessment of Muscle Tension

  Measuring patients' symptomatic experiences through questionnaires or self-reports is the gold standard method for assessing the presence and severity of a mental disorder. In a study conducted by Sainsbury and Gibson (1954) on symptoms reported by anxious, stressed patients, "feeling of tension" was mostly defined as "feeling of tension in the muscles," "muscle stiffness," "cramping," and "body discomfort" line with this information, the 10-point Visual Analogy Scale (VAS) will be used to assess muscle tension resulting from stress in patients before the CAG procedure, and patients will be asked to rate their feelings of tension in the muscles, stiffness in the muscles, cramping in any muscle, and inability to relax their body using this scale. This scale is 10 centimeters (cm) long and includes numbers from 0 to 10. The values marked by the patient between 0-10 cm on the scale will be ta

  Preoperative period

• Physiological Parameters Monitoring Form

  This form includes questions about patients' systolic and diastolic blood pressure

  Preoperative period

• Physiological Parameters Monitoring Form

  This form includes question about patients' pulse

  Preoperative period

• Physiological Parameters Monitoring Form

  This form includes question about patients' respiratory rate

  Preoperative period

• Physiological Parameters Monitoring Form

  This form includes question about patients' oxygen saturation.

  Preoperative period

Secondary Outcomes (6)

• Distress Thermometer

  Approximately 10 minutes before the procedure, patients

• Assessment of Muscle Tension

  About 10 minutes before entering the process

• Physiological Parameters Monitoring Form

  About 10 minutes before entering the process

• Physiological Parameters Monitoring Form

  About 10 minutes before entering the process

• Physiological Parameters Monitoring Form

  About 10 minutes before entering the process

Study Arms (2)

Control Group

OTHER

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.

Behavioral: Standard application

Experimental Group

EXPERIMENTAL

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.

Behavioral: Intervention application with virtual reality glasses

Interventions

Intervention application with virtual reality glasses 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.

Experimental Group

Standard application 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.

Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Yüksek İhtisas University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

Central Study Contacts

Aylin GÜÇLÜ DEMİREL Assistant Professor (PhD), PhD

CONTACT

+90 5064384935; aylinguclu11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (PhD)

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 14, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)