An interventional study of Intervention application with virtual reality glasses and Standard application in Coronary Angiography (CAG), sponsored by Yuksek Ihtisas University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Yuksek Ihtisas University · Not applicable, Interventional, and Prevention
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.
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.
Yuksek Ihtisas University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - 18-65 years of age,
Exclusion Criteria: Patients with nausea,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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
Time frame: Preoperative period
Physiological Parameters Monitoring Form
This form includes questions about patients' systolic and diastolic blood pressure
Time frame: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' pulse
Time frame: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' respiratory rate
Time frame: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' oxygen saturation.
Time frame: Preoperative period
Distress Thermometer
The patients were reapplied approximately 10 minutes before the procedure to measure their stress levels.
Time frame: Approximately 10 minutes before the procedure, patients
Assessment of Muscle Tension
Patients will be asked to rate whether they feel tension in their muscles, a feeling of stiffness in their muscles, a feeling of cramping in any muscle, or an inability to relax their body.
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked questions about their systolic and diastolic blood pressure
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question about pulse
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question respiratory rate
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question about oxygen saturation.
Time frame: About 10 minutes before entering the process
Plan to share: No
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Yuksek Ihtisas University