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

NCT07360054 | Completed

• 1 other identifier: VR-FEM-SHEATH-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Anxiety; Hemodynamic Response; Coronary Artery Disease

Keywords

Virtual Reality, Pain Management, Anxiety, Femoral Catheter Removal

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured by Visual Analog Scale (VAS)

  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 Outcomes (6)

• Anxiety level measured by State Anxiety Inventory (STAI-S)

  Before sheath removal (baseline) and immediately after sheath removal

• Heart rate measured 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

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

• Diastolic blood pressure measured in mmHg

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

• Respiratory rate measured in breaths per minute

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

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants received a virtual reality application during femoral catheter removal in addition to routine clinical care.

Other: Virtual Reality

Control Group

NO INTERVENTION

Participants received routine clinical care during femoral catheter removal without any additional intervention.

Interventions

Virtual Reality OTHER

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

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Coronary Artery Disease; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned to either the virtual reality intervention group or the control group receiving routine care, and both groups were followed in parallel throughout the study.

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 22, 2026
• Study Start: September 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)