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NCT Number: NCT07653763

Effect of Virtual Reality During Femoral Sheath Removal

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.

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Key information

Conditions

Percutaneous Coronary Intervention Anxiety Disorders Femoral Sheath Removal Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İskenderun Devlet Hastanesi

İskenderun, Hatay, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual reality

Device

Virtual reality glasses were used during femoral sheath removal.

Routine care

Other

Participants received routine care during femoral sheath removal

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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