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

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Femoral Sheath Removal
• Intervention / Treatment: Device: Virtual Reality; Other: Routine Care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Hatay
    • İskenderun, Hatay, Turkey (Türkiye)
      • İskenderun Devlet Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Participants received virtual reality glasses during femoral sheath removal	Device: Virtual Reality; Virtual reality glasses were used during femoral sheath removal.
Other: Control Group; Participants received routine care during femoral sheath removal	Other: Routine Care; Participants received routine care during femoral sheath removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate was measured in beats per minute using routine monitoring.	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.	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.	Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Body Temperature	Body temperature was assessed using routine vital sign monitoring.	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.	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.	Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Virtual Reality; Nursing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: HKU-2025/069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and confidentiality considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No