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Completed

NCT Number: NCT07360054

Effect of Virtual Reality on Pain, Anxiety, and Vital Signs During Femoral Catheter Removal

Femoral catheter removal after coronary angiography is a common clinical procedure that may cause pain, anxiety, and changes in vital signs in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and safety during invasive procedures.

The purpose of this randomized controlled study is to evaluate the effect of a virtual reality (VR) application on pain, anxiety, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Participants were randomly assigned to either a virtual reality group or a control group receiving routine care. Patients in the intervention group experienced a virtual reality application during femoral catheter removal, while the control group received standard clinical care.

Pain intensity, anxiety levels, and vital signs were assessed before, during, and after the procedure. The findings of this study are expected to contribute to evidence-based nursing practice by supporting the use of virtual reality as a safe and effective non-pharmacological method to reduce discomfort during femoral catheter removal.

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Key information

Conditions

Pain Agnosia Anxiety Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Hemodynamic Response Mental Disorders Myocardial Ischemia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

About this study

Coronary angiography is a widely used diagnostic procedure in cardiology, and femoral arterial access remains common in many clinical settings. Removal of the femoral catheter following the procedure is frequently associated with pain, anxiety, and physiological responses such as changes in blood pressure and heart rate. These symptoms may negatively affect patient comfort and overall procedural experience.

Virtual reality (VR) is a non-pharmacological intervention that provides immersive audiovisual stimulation and has been shown to reduce pain and anxiety by diverting attention and promoting relaxation. However, evidence regarding its effectiveness during femoral catheter removal after coronary angiography remains limited.

This single-center, randomized controlled trial was conducted to determine the effect of virtual reality on pain intensity, anxiety levels, and vital signs during femoral catheter removal in patients undergoing coronary angiography. Eligible patients were randomly assigned to either the virtual reality intervention group or the control group. Patients in the intervention group received a virtual reality application during femoral catheter removal, while patients in the control group received routine clinical care.

Data were collected using a patient information form, a visual analog scale for pain assessment, a standardized anxiety assessment tool, and vital signs monitoring. Measurements were obtained before, during, and after femoral catheter removal. The results of this study aim to provide evidence supporting the integration of virtual reality into nursing care practices to enhance patient comfort and improve the quality of care during invasive cardiovascular procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Ability to speak and understand Turkish
  • Undergoing elective coronary angiography with femoral arterial access
  • Planned femoral sheath removal
  • Hemodynamically stable vital signs
  • No psychiatric, cognitive, visual, or hearing impairment
  • No administration of analgesics for any reason prior to sheath removal

Exclusion criteria

  • Use of analgesics for chronic pain prior to the procedure
  • Impaired orientation to time or place
  • Use of anxiolytic and/or sedative medications

Treatment and study plan

Virtual Reality

Other

A virtual reality application providing immersive audiovisual content was used during femoral catheter removal to reduce pain and anxiety.

Primary outcomes

  1. Pain intensity measured by Visual Analog Scale (VAS)

    Time frame: Before femoral sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain). Higher scores indicate greater pain intensity.

Secondary outcomes

  1. Anxiety level measured by State Anxiety Inventory (STAI-S)

    Time frame: Before sheath removal (baseline) and immediately after sheath removal

    Anxiety will be measured using the State-Trait Anxiety Inventory - State Form (STAI-S), assessing state (situational) anxiety only.

    The scale consists of 20 items, with scores ranging from 20 (low anxiety) to 80 (high anxiety). Higher scores indicate greater anxiety.

  2. Heart rate measured in beats per minute (bpm)

    Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Heart rate will be measured using standard clinical monitoring equipment and reported in beats per minute (bpm).

  3. Systolic blood pressure measured in mmHg

    Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Systolic blood pressure will be measured using non-invasive monitoring and reported in millimeters of mercury (mmHg).

  4. Diastolic blood pressure measured in mmHg

    Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Diastolic blood pressure will be measured using non-invasive monitoring and reported in millimeters of mercury (mmHg).

  5. Respiratory rate measured in breaths per minute

    Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Respiratory rate will be measured via standard clinical observation and reported as breaths per minute.

  6. Oxygen saturation measured by pulse oximetry (SpO₂ %)

    Time frame: Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

    Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as percentage (%).

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs During Femoral Sheath Removal After Coronary Angiography: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2026
Registry last updated
Jan 22, 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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