Clinical trial NCT06969885: Effect of Virtual Reality Glasses on Stress, Muscle Tension, and Physiological Parameters Before Angiography
Official title: The Effect of Virtual Reality Glasses Applied Before Coronary Angiography on Patients' Stress Levels, Muscle Tension, and Certain Physiological Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Angiography (CAG)
Keywords: Coronary Angiography
Virtual Reality Glasses
Stress
Muscle Tension
Physiological Parameters
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria: - 18-65 years of age,

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

Exclusion Criteria: Patients with nausea,

* 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.

Primary outcomes:
measure: Distress Thermometer
timeFrame: Preoperative period
measure: Assessment of Muscle Tension
timeFrame: Preoperative period
measure: Physiological Parameters Monitoring Form
timeFrame: Preoperative period
measure: Physiological Parameters Monitoring Form
timeFrame: Preoperative period
measure: Physiological Parameters Monitoring Form
timeFrame: Preoperative period
measure: Physiological Parameters Monitoring Form
timeFrame: Preoperative period
Secondary outcomes:
measure: Distress Thermometer
timeFrame: Approximately 10 minutes before the procedure, patients
measure: Assessment of Muscle Tension
timeFrame: About 10 minutes before entering the process
measure: Physiological Parameters Monitoring Form
timeFrame: About 10 minutes before entering the process
measure: Physiological Parameters Monitoring Form
timeFrame: About 10 minutes before entering the process
measure: Physiological Parameters Monitoring Form
timeFrame: About 10 minutes before entering the process
measure: Physiological Parameters Monitoring Form
timeFrame: About 10 minutes before entering the process
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yüksek İhtisas University
state: Çankaya
Study officials:
References: