PainNCT07360054
Effect of Virtual Reality on Pain, Anxiety, and Vital Signs During Femoral Catheter Removal
A study testing Virtual Reality in people with Pain and Anxiety, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Femoral catheter removal after coronary angiography is a common clinical procedure that may cause pain, anxiety, and changes in vital signs in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and safety during invasive procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anxiety, Hemodynamic Response
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Ability to speak and understand Turkish
- Undergoing elective coronary angiography with femoral arterial access
- Planned femoral sheath removal
- Hemodynamically stable vital signs
- No psychiatric, cognitive, visual, or hearing impairment
- No administration of analgesics for any reason prior to sheath removal
Who cannot join
- Use of analgesics for chronic pain prior to the procedure
- Impaired orientation to time or place
- Use of anxiolytic and/or sedative medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs During Femoral Sheath Removal After Coronary Angiography: A Randomized Controlled Trial
Femoral catheter removal after coronary angiography is a common clinical procedure that may cause pain, anxiety, and changes in vital signs in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and safety during invasive procedures.
The purpose of this randomized controlled study is to evaluate the effect of a virtual reality (VR) application on pain, anxiety, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Participants were randomly assigned to either a virtual reality group or a control group receiving routine care. Patients in the intervention group experienced a virtual reality application during femoral catheter removal, while the control group received standard clinical care.
Pain intensity, anxiety levels, and vital signs were assessed before, during, and after the procedure. The findings of this study are expected to contribute to evidence-based nursing practice by supporting the use of virtual reality as a safe and effective non-pharmacological method to reduce discomfort during femoral catheter removal.
Read the detailed description
Coronary angiography is a widely used diagnostic procedure in cardiology, and femoral arterial access remains common in many clinical settings. Removal of the femoral catheter following the procedure is frequently associated with pain, anxiety, and physiological responses such as changes in blood pressure and heart rate. These symptoms may negatively affect patient comfort and overall procedural experience.
Virtual reality (VR) is a non-pharmacological intervention that provides immersive audiovisual stimulation and has been shown to reduce pain and anxiety by diverting attention and promoting relaxation. However, evidence regarding its effectiveness during femoral catheter removal after coronary angiography remains limited.
This single-center, randomized controlled trial was conducted to determine the effect of virtual reality on pain intensity, anxiety levels, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Eligible patients were randomly assigned to either the virtual reality intervention group or the control group. Patients in the intervention group received a virtual reality application during femoral catheter removal, while patients in the control group received routine clinical care.
Data were collected using a patient information form, a visual analog scale for pain assessment, a standardized anxiety assessment tool, and vital signs monitoring. Measurements were obtained before, during, and after femoral catheter removal. The results of this study aim to provide evidence supporting the integration of virtual reality into nursing care practices to enhance patient comfort and improve the quality of care during invasive cardiovascular procedures.
- Conditions
- Pain, Anxiety, Hemodynamic Response, Coronary Artery Disease
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain Management, Anxiety, Femoral Catheter Removal
- Medical subject headings
- Pain, Anxiety Disorders, Coronary Artery Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
A virtual reality application providing immersive audiovisual content was used during femoral catheter removal to reduce pain and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants received a virtual reality application during femoral catheter removal in addition to routine clinical care. Receives: Other: Virtual Reality |
| Control Group | No intervention | Participants received routine clinical care during femoral catheter removal without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain). Higher scores indicate greater pain intensity.
Measured: Before femoral sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Secondary outcomes (6)
Anxiety level measured by State Anxiety Inventory (STAI-S)
Anxiety will be measured using the State-Trait Anxiety Inventory - State Form (STAI-S), assessing state (situational) anxiety only.
The scale consists of 20 items, with scores ranging from 20 (low anxiety) to 80 (high anxiety). Higher scores indicate greater anxiety.
Measured: Before sheath removal (baseline) and immediately after sheath removal
Heart rate measured in beats per minute (bpm)
Heart rate will be measured using standard clinical monitoring equipment and reported in beats per minute (bpm).
Measured: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Systolic blood pressure measured in mmHg
Systolic blood pressure will be measured using non-invasive monitoring and reported in millimeters of mercury (mmHg).
Measured: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Diastolic blood pressure measured in mmHg
Diastolic blood pressure will be measured using non-invasive monitoring and reported in millimeters of mercury (mmHg).
Measured: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Respiratory rate measured in breaths per minute
Respiratory rate will be measured via standard clinical observation and reported as breaths per minute.
Measured: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Oxygen saturation measured by pulse oximetry (SpO₂ %)
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as percentage (%).
Measured: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the virtual reality intervention group or the control group receiving routine care, and both groups were followed in parallel throughout the study.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Korkmaz, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360054
- Sponsor's protocol ID
- VR-FEM-SHEATH-01
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality. The data are used solely for the purposes of this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs During Femoral Sheath Removal After Coronary Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07360054
- Acronym / sponsor ID
- VR-FEM-SHEATH-01
- Conditions
- Pain, Anxiety, Hemodynamic Response, Coronary Artery Disease
- Keywords
- Virtual Reality, Pain Management, Anxiety, Femoral Catheter Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 Jan 2026 (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.
Femoral catheter removal after coronary angiography is a common clinical procedure that may cause pain, anxiety, and changes in vital signs in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and safety during invasive procedures.
The purpose of this randomized controlled study is to evaluate the effect of a virtual reality (VR) application on pain, anxiety, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Participants were randomly assigned to either a virtual reality group or a control group receiving routine care. Patients in the intervention group experienced a virtual reality application during femoral catheter removal, while the control group received standard clinical care.
Pain intensity, anxiety levels, and vital signs were assessed before, during, and after the procedure. The findings of this study are expected to contribute to evidence-based nursing practice by supporting the use of virtual reality as a safe and effective non-pharmacological method to reduce discomfort during femoral catheter removal.
Detailed description
Coronary angiography is a widely used diagnostic procedure in cardiology, and femoral arterial access remains common in many clinical settings. Removal of the femoral catheter following the procedure is frequently associated with pain, anxiety, and physiological responses such as changes in blood pressure and heart rate. These symptoms may negatively affect patient comfort and overall procedural experience.
Virtual reality (VR) is a non-pharmacological intervention that provides immersive audiovisual stimulation and has been shown to reduce pain and anxiety by diverting attention and promoting relaxation. However, evidence regarding its effectiveness during femoral catheter removal after coronary angiography remains limited.
This single-center, randomized controlled trial was conducted to determine the effect of virtual reality on pain intensity, anxiety levels, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Eligible patients were randomly assigned to either the virtual reality intervention group or the control group. Patients in the intervention group received a virtual reality application during femoral catheter removal, while patients in the control group received routine clinical care.
Data were collected using a patient information form, a visual analog scale for pain assessment, a standardized anxiety assessment tool, and vital signs monitoring. Measurements were obtained before, during, and after femoral catheter removal. The results of this study aim to provide evidence supporting the integration of virtual reality into nursing care practices to enhance patient comfort and improve the quality of care during invasive cardiovascular procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the virtual reality intervention group or the control group receiving routine care, and both groups were followed in parallel throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual RealityParticipants received a virtual reality application during femoral catheter removal in addition to routine clinical care. |
| Control Group | No intervention | –Participants received routine clinical care during femoral catheter removal without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Ability to speak and understand Turkish
- Undergoing elective coronary angiography with femoral arterial access
- Planned femoral sheath removal
- Hemodynamically stable vital signs
Key exclusion criteria (3 listed)
- Use of analgesics for chronic pain prior to the procedure
- Impaired orientation to time or place
- Use of anxiolytic and/or sedative medications
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 RealityA virtual reality application providing immersive audiovisual content was used during femoral catheter removal to reduce pain and anxiety. | Other | Virtual Reality Group |
Primary outcome
Pain intensity measured by Visual Analog Scale (VAS)
Time frame: Before femoral sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain). Higher scores indicate greater pain intensity.
6 secondary outcomes
Anxiety level measured by State Anxiety Inventory (STAI-S)
Time frame: Before sheath removal (baseline) and immediately after sheath removal
Heart rate measured in beats per minute (bpm)
Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Systolic blood pressure measured in mmHg
Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Diastolic blood pressure measured in mmHg
Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Respiratory rate measured in breaths per minute
Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
Oxygen saturation measured by pulse oximetry (SpO₂ %)
Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
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 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality. The data are used solely for the purposes of this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Pain and Anxiety, run by Kirsehir Ahi Evran Universitesi 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 7 inclusion and 3 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 22 Jan 2026. 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?
Pain intensity measured by Visual Analog Scale (VAS) (time frame: Before femoral sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal). 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 22 Jan 2026.