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

January 14, 2026 updated by: Emine Korkmaz, Kirsehir Ahi Evran Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Participants received a virtual reality application during femoral catheter removal in addition to routine clinical care.
Other: Virtual Reality
A virtual reality application providing immersive audiovisual content was used during femoral catheter removal to reduce pain and anxiety.
No Intervention: Control Group
Participants received routine clinical care during femoral catheter removal without any additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before femoral sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before sheath removal (baseline) and immediately after sheath removal
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).
Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
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).
Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
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).
Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
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.
Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal
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 (%).
Before sheath removal (baseline), during femoral sheath removal (procedural period), and immediately after sheath removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsehir Ahi Evran Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR-FEM-SHEATH-01

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 ethical restrictions and to protect participant confidentiality. The data are used solely for the purposes of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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