Virtual RealityNCT07117838
Vırtual Reality and Music in Coronary Angiography
A study testing virtual reality and music in people with Virtual Reality and Nursing Caries, run by HARUN ÜNAL at 1 site in Turkey (Türkiye).
Trial summary
"Coronary The scope of this study, which was conducted for the purpose of "Distracting Interventions on Patients' Anxiety, Pain and Physiological Parameters During Angiography: The Effect of Virtual Reality and Music", is to help patients at the level of evidence during coronary angiography and to contribute to the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Virtual Reality, Nursing Caries
- What is being tested?
- virtual reality and music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2024to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-70, Patients who agreed to participate in the study voluntarily, Open to communication, Knows how to read and write, Patients without visual or auditory impairments, Patients who underwent femoral artery area intervention, Patients who are administered opioid and tranquilizer derivative drugs, Patients who were undergoing coronary angiography for the first time were included in the study.
Who cannot join
- Having difficulty using virtual reality glasses, Patients with headache, nausea and vomiting were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distractional Interventions on Patients' Anxiety, Pain and Physiological Parameters Durıng Coronary Angiography: The Effect of Virtual Reality and Music
"Coronary The scope of this study, which was conducted for the purpose of "Distracting Interventions on Patients' Anxiety, Pain and Physiological Parameters During Angiography: The Effect of Virtual Reality and Music", is to help patients at the level of evidence during coronary angiography and to contribute to the literature.
Read the detailed description
Before starting the application, patients who meet the criteria for inclusion in the study will be determined according to the randomization order and information about the study will be given.
Patients will be randomly assigned to the control and intervention groups (virtual reality and music group). Then, the following interventions will be applied sequentially, depending on the group the patient is included in.
After the appropriate participants are determined, written informed consent will be given to the participants and the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied just before the procedure begins, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form. Later patients will undergo coronary angiography. For the control group, conventional procedures will be applied by the researcher and medical care staff.
Patients in the virtual reality group, one of the intervention groups, will be shown a video with predetermined relaxing visuals and sounds through virtual reality glasses. Before watching the video, the researcher informed about the use of virtual reality glasses.
The patient will be informed. They will use the SG glasses for 3-5 minutes before the procedure begins for the patient to get used to it, and then the procedure will begin. VR glasses will be kept on throughout the procedure. In addition, the patient is advised at any stage of the application.
He will be told that he can remove his glasses and withdraw from the study. USB MP3 players and headphones will be provided by the researcher to collect data for the music group. Various styles of music (Classical World Music, Popular Music, Classical Turkish Music, Sufi Music) will be loaded into the USB MP3 player. Patients will be able to choose any of these music styles from the folder and listen to them. Music group patients from the intervention groups will be informed before starting the procedure and will be given 3-5 minutes.
MP3 reader and headphones will be provided throughout. Then, the patient will be taken to the coronary angiography procedure and will be allowed to listen to the previously prepared music of the patient's choice throughout the procedure.
Physiological parameters of patients during coronary angiography will be measured. After the procedure is completed, the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied to the patients in all three groups, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form.
- Conditions
- Virtual Reality, Nursing Caries
- Being tested
- virtual reality, music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Virtual reality application were applied to patients during coronary angiography.
musicOther
Patients will listen to music during coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Patients were fitted with virtual reality glasses. Receives: Other: virtual reality |
| music | Experimental | Patients were listened to music Receives: Other: music |
| control | No intervention | Patients were not interfered with and were receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
This form, prepared by researchers based on literature reviews, consists of a total of 13 questions to question the socio-demographic characteristics of patients and their disease-related characteristics.
Measured: 10 minutes
Visual Analog Scale
The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences. The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales. To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain." The scale can be applied horizontally or vertically. The point marked by the patient is used as numerical data to determine the level of pain perception. On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.
Measured: 10 minutes
State Anxiety Scale
The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Oner and Le Compte (1998). The scale consists of a total of 40 items and two separate scales. The first section includes the "State Anxiety Scale," which measures how a person feels in a given moment. The second section includes the "Trait Anxiety Scale," which also includes statements about how a person generally feels. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on literature research and expert opinions.
Measured: 10 minutes
Patient Follow-up Form
This is a form created by researchers to record the physiological parameters (heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation) measured by researchers before (manually), during (digitally via a femoral catheter), and after the procedure (digitally via a femoral catheter). The measurements taken from the patient were recorded on this form.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start8 Apr 2024
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One count for 120 patients who met the study's inclusion criteria A list will be created and patients will be distributed to experimental and intervention groups with a computerized randomization program (https://www.random.org/integer-sets/). According to the randomization result, patients will be assigned to the virtual reality group (intervention 1), the music group (intervention 2) and the control group (Control) with standard treatment. All patients will be randomized to the intervention and control groups after being admitted to the angiography unit. - It will be named as intervention group (the group to which virtual reality glasses and music will be applied) and - Control group (the group to which no additional procedure will be applied to the standard care during the coronary angiography procedure).
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- HARUN ÜNAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HARUN ÜNAL, Ataturk University
- Investigators
- Harun ÜNAL, phd student, Study chair, ataturk universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117838
- Sponsor's protocol ID
- 1476
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2025
- Last updated
- 8 Sep 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distractional Interventions on Patients' Anxiety, Pain and Physiological Parameters Durıng Coronary Angiography: The Effect of Virtual Reality and Music
- ClinicalTrials.gov ID
- NCT07117838
- Acronym / sponsor ID
- 1476
- Conditions
- Virtual Reality, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- HARUN ÜNALUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 12 Aug 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.
"Coronary The scope of this study, which was conducted for the purpose of "Distracting Interventions on Patients' Anxiety, Pain and Physiological Parameters During Angiography: The Effect of Virtual Reality and Music", is to help patients at the level of evidence during coronary angiography and to contribute to the literature.
Detailed description
Before starting the application, patients who meet the criteria for inclusion in the study will be determined according to the randomization order and information about the study will be given.
Patients will be randomly assigned to the control and intervention groups (virtual reality and music group). Then, the following interventions will be applied sequentially, depending on the group the patient is included in.
After the appropriate participants are determined, written informed consent will be given to the participants and the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied just before the procedure begins, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form. Later patients will undergo coronary angiography. For the control group, conventional procedures will be applied by the researcher and medical care staff.
Patients in the virtual reality group, one of the intervention groups, will be shown a video with predetermined relaxing visuals and sounds through virtual reality glasses. Before watching the video, the researcher informed about the use of virtual reality glasses.
The patient will be informed. They will use the SG glasses for 3-5 minutes before the procedure begins for the patient to get used to it, and then the procedure will begin. VR glasses will be kept on throughout the procedure. In addition, the patient is advised at any stage of the application.
He will be told that he can remove his glasses and withdraw from the study. USB MP3 players and headphones will be provided by the researcher to collect data for the music group. Various styles of music (Classical World Music, Popular Music, Classical Turkish Music, Sufi Music) will be loaded into the USB MP3 player. Patients will be able to choose any of these music styles from the folder and listen to them. Music group patients from the intervention groups will be informed before starting the procedure and will be given 3-5 minutes.
MP3 reader and headphones will be provided throughout. Then, the patient will be taken to the coronary angiography procedure and will be allowed to listen to the previously prepared music of the patient's choice throughout the procedure.
Physiological parameters of patients during coronary angiography will be measured. After the procedure is completed, the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied to the patients in all three groups, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One count for 120 patients who met the study's inclusion criteria A list will be created and patients will be distributed to experimental and intervention groups with a computerized randomization program (https://www.random.org/integer-sets/). According to the randomization result, patients will be assigned to the virtual reality group (intervention 1), the music group (intervention 2) and the control group (Control) with standard treatment. All patients will be randomized to the intervention and control groups after being admitted to the angiography unit. - It will be named as intervention group (the group to which virtual reality glasses and music will be applied) and - Control group (the group to which no additional procedure will be applied to the standard care during the coronary angiography procedure).
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Other: virtual realityPatients were fitted with virtual reality glasses. |
| music | Experimental | Other: musicPatients were listened to music |
| control | No intervention | –Patients were not interfered with and were receive standard care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between the ages of 18-70, Patients who agreed to participate in the study voluntarily, Open to communication, Knows how to read and write, Patients without visual or auditory impairments, Patients who underwent femoral artery area intervention, Patients who are administered opioid and tranquilizer derivative drugs, Patients who were undergoing coronary angiography for the first time were included in the study.
Key exclusion criteria (1 listed)
- Having difficulty using virtual reality glasses, Patients with headache, nausea and vomiting were not included in the study.
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 |
|---|---|---|
| virtual realityVirtual reality application were applied to patients during coronary angiography. | Other | virtual reality |
| musicPatients will listen to music during coronary angiography. | Other | music |
Primary outcome
Patient Identification Form
Time frame: 10 minutes
This form, prepared by researchers based on literature reviews, consists of a total of 13 questions to question the socio-demographic characteristics of patients and their disease-related characteristics.
Visual Analog Scale
Time frame: 10 minutes
The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences. The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales. To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain." The scale can be applied horizontally or vertically. The point marked by the patient is used as numerical data to determine the level of pain perception. On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.
State Anxiety Scale
Time frame: 10 minutes
The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Oner and Le Compte (1998). The scale consists of a total of 40 items and two separate scales. The first section includes the "State Anxiety Scale," which measures how a person feels in a given moment. The second section includes the "Trait Anxiety Scale," which also includes statements about how a person generally feels. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on literature research and expert opinions.
Patient Follow-up Form
Time frame: 10 minutes
This is a form created by researchers to record the physiological parameters (heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation) measured by researchers before (manually), during (digitally via a femoral catheter), and after the procedure (digitally via a femoral catheter). The measurements taken from the patient were recorded on this form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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. This study is not recruiting at the moment.
Harun ÜNAL, phd student study chair
ataturk universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and music in people with Virtual Reality and Nursing Caries, run by HARUN ÜNAL 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: 10 minutes). The study lists 4 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 8 Sep 2025.