Effect of Virtual Reality During Femoral Sheath Removal

NCT07653763 | Completed

• 1 other identifier: HKU-2025/069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Femoral Sheath Removal

Keywords

Virtual Reality; Pain; Anxiety; Nursing

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants received virtual reality glasses during femoral sheath removal

Device: Virtual Reality

Control Group

OTHER

Participants received routine care during femoral sheath removal

Other: Routine Care

Interventions

Virtual Reality DEVICE

Virtual reality glasses were used during femoral sheath removal.

Virtual Reality Group

Routine Care OTHER

Participants received routine care during femoral sheath removal

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

İskenderun Devlet Hastanesi

İskenderun, Hatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Nursing Student

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 17, 2026
• Study Start: July 1, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)