Effect of Virtual Reality During Femoral Sheath Removal (NCT07653763) | Clinical Trial Compass
CompletedNot Applicable
Effect of Virtual Reality During Femoral Sheath Removal
Turkey (Türkiye)60 participantsStarted 2025-07-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Patients without visual, hearing, or speech impairment
* Patients without mental impairment affecting communication
* Patients without psychiatric diagnosis and not using psychiatric medication
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart Rate
Timeframe: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
2
Blood Pressure
Timeframe: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
3
Oxygen Saturation
Timeframe: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
4
Body Temperature
Timeframe: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
5
Pain Level
Timeframe: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
6
Anxiety Level
Timeframe: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal