Percutaneous Coronary InterventionNCT07653763
Effect of Virtual Reality During Femoral Sheath Removal
A study testing Virtual Reality and Routine Care in people with Percutaneous Coronary Intervention and Femoral Sheath Removal, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was conducted to evaluate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Femoral Sheath Removal
- What is being tested?
- Virtual Reality and Routine Care
- Type of treatment
- Medical device
- 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 5 Jan 2026
- 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
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
- Patients able to communicate in Turkish
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- Patients without visual, hearing, or speech impairment
- Patients without mental impairment affecting communication
- Patients without psychiatric diagnosis and not using psychiatric medication
Who cannot join
- Patients unwilling to participate or wishing to withdraw from the study at any stage
- Patients who removed the virtual reality glasses during the intervention
- Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
This randomized controlled study was conducted to evaluate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were assigned to either a virtual reality intervention group or a control group receiving standard care. Pain, anxiety, and vital signs were assessed before, during, and after the procedure. The study aimed to determine whether virtual reality application could improve patient comfort and reduce procedure-related discomfort during femoral sheath removal.
Read the detailed description
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
- Being tested
- Virtual Reality, Routine Care
- Keywords
- Virtual Reality, Pain, Anxiety, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual reality glasses were used during femoral sheath removal.
Routine CareOther
Participants received routine care during femoral sheath removal
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants received virtual reality glasses during femoral sheath removal Receives: Device: Virtual Reality |
| Control Group | Other | Participants received routine care during femoral sheath removal Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate was measured in beats per minute using routine monitoring.
Measured: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Blood Pressure
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
Measured: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen Saturation
Oxygen saturation was measured as percent saturation using pulse oximetry.
Measured: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Body Temperature
Body temperature was assessed using routine vital sign monitoring.
Measured: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain Level
Pain level was assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain severity.
Measured: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Anxiety Level
Anxiety level was assessed using the State Anxiety Inventory (STAI). Higher scores indicate higher anxiety levels.
Measured: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem Canavar, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653763
- Sponsor's protocol ID
- HKU-2025/069
- Status last verified
- Jun 2026
- First submitted
- 8 May 2026
- Last updated
- 17 Jun 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 privacy and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07653763
- Acronym / sponsor ID
- HKU-2025/069
- Keywords
- Virtual Reality, Pain, Anxiety, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 17 Jun 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.
This randomized controlled study was conducted to evaluate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were assigned to either a virtual reality intervention group or a control group receiving standard care. Pain, anxiety, and vital signs were assessed before, during, and after the procedure. The study aimed to determine whether virtual reality application could improve patient comfort and reduce procedure-related discomfort during femoral sheath removal.
Detailed description
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual RealityParticipants received virtual reality glasses during femoral sheath removal |
| Control Group | Other | Other: Routine CareParticipants received routine care during femoral sheath removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
Key exclusion criteria (3 listed)
- Patients unwilling to participate or wishing to withdraw from the study at any stage
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 glasses were used during femoral sheath removal. | Device | Virtual Reality Group |
| Routine CareParticipants received routine care during femoral sheath removal | Other | Control Group |
Primary outcome
Heart Rate
Time frame: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Heart rate was measured in beats per minute using routine monitoring.
Blood Pressure
Time frame: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
Oxygen Saturation
Time frame: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen saturation was measured as percent saturation using pulse oximetry.
Body Temperature
Time frame: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Body temperature was assessed using routine vital sign monitoring.
Pain Level
Time frame: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain level was assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain severity.
Anxiety Level
Time frame: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
Anxiety level was assessed using the State Anxiety Inventory (STAI). Higher scores indicate higher anxiety levels.
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 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations
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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 and Routine Care in people with Percutaneous Coronary Intervention and Femoral Sheath Removal, run by Hasan Kalyoncu 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 9 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 17 Jun 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?
Heart Rate (time frame: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)). 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 17 Jun 2026.