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Effect of Virtual Reality During Femoral Sheath Removal

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07653763
Enrollment
60
Registered
2026-06-17
Start date
2025-07-01
Completion date
2026-01-05
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Sheath Removal, Percutaneous Coronary Intervention

Keywords

Virtual Reality, Pain, Anxiety, Nursing

Brief 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.

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.

Interventions

DEVICEVirtual Reality

Virtual reality glasses were used during femoral sheath removal.

OTHERRoutine Care

Participants received routine care during femoral sheath removal

Sponsors

Hasan Kalyoncu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Heart RatePeriprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)Heart rate was measured in beats per minute using routine monitoring.
Blood PressurePeriprocedural (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 SaturationPeriprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)Oxygen saturation was measured as percent saturation using pulse oximetry.
Body Temperature5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removalBody temperature was assessed using routine vital sign monitoring.
Pain Level5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removalPain 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 LevelBefore femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removalAnxiety level was assessed using the State Anxiety Inventory (STAI). Higher scores indicate higher anxiety levels.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026