Coronary Angiography (CAG)NCT06969885
Effect of Virtual Reality Glasses on Stress, Muscle Tension, and Physiological Parameters Before Angiography
A study testing Intervention application with virtual reality glasses and Standard application in people with Coronary Angiography (CAG), run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Angiography (CAG)
- What is being tested?
- Intervention application with virtual reality glasses and Standard application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo CAG,
- American Society of Anesthesiologists (ASA) score I or II,
- Turkish-speaking patients will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Yüksek İhtisas University
Ankara, Çankaya, 06520
About this study
Official title: The Effect of Virtual Reality Glasses Applied Before Coronary Angiography on Patients' Stress Levels, Muscle Tension, and Certain Physiological Parameters
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.
Read the 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)
- Being tested
- Intervention application with virtual reality glasses, Standard application
- Keywords
- Coronary Angiography, Virtual Reality Glasses, Stress, Muscle Tension, Physiological Parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention application with virtual reality glassesBehavioural
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.
Standard applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Intervention application with virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Preoperative period
Physiological Parameters Monitoring Form
This form includes questions about patients' systolic and diastolic blood pressure
Measured: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' pulse
Measured: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' respiratory rate
Measured: Preoperative period
Physiological Parameters Monitoring Form
This form includes question about patients' oxygen saturation.
Measured: Preoperative period
Secondary outcomes (6)
Distress Thermometer
The patients were reapplied approximately 10 minutes before the procedure to measure their stress levels.
Measured: 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.
Measured: 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
Measured: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question about pulse
Measured: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question respiratory rate
Measured: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Approximately 10 minutes before the procedure, patients are asked question about oxygen saturation.
Measured: About 10 minutes before entering the process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Angiography (CAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin GÜÇLÜ DEMİREL, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969885
- Sponsor's protocol ID
- 2024/215
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Applied Before Coronary Angiography on Patients' Stress Levels, Muscle Tension, and Certain Physiological Parameters
- ClinicalTrials.gov ID
- NCT06969885
- Acronym / sponsor ID
- 2024/215
- Conditions
- Coronary Angiography (CAG)
- Keywords
- Coronary Angiography, Virtual Reality Glasses, Stress, Muscle Tension, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Behavioral: Standard applicationNo 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 | Experimental | Behavioral: Intervention application with virtual reality glassesIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo CAG,
- American Society of Anesthesiologists (ASA) score I or II,
- Turkish-speaking patients will be included.
Key exclusion criteria (8 listed)
- with dizziness,
- with headache,
- with any known psychiatric disease and mental perception problem,
- pregnant,
- with a history of epilepsy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention application with virtual reality glassesIn 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. | Behavioural | Experimental Group |
| Standard applicationNo 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. | Behavioural | Control Group |
Primary outcome
Distress Thermometer
Time frame: Preoperative period
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.
Assessment of Muscle Tension
Time frame: Preoperative period
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
Physiological Parameters Monitoring Form
Time frame: Preoperative period
This form includes questions about patients' systolic and diastolic blood pressure
Physiological Parameters Monitoring Form
Time frame: Preoperative period
This form includes question about patients' pulse
Physiological Parameters Monitoring Form
Time frame: Preoperative period
This form includes question about patients' respiratory rate
Physiological Parameters Monitoring Form
Time frame: Preoperative period
This form includes question about patients' oxygen saturation.
6 secondary outcomes
Distress Thermometer
Time frame: Approximately 10 minutes before the procedure, patients
Assessment of Muscle Tension
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Time frame: About 10 minutes before entering the process
Physiological Parameters Monitoring Form
Time frame: About 10 minutes before entering the process
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention application with virtual reality glasses and Standard application in people with Coronary Angiography (CAG), run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aylin GÜÇLÜ DEMİREL Assistant Professor (PhD), PhD (+90 5064384935, aylinguclu11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress Thermometer (time frame: Preoperative period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.