Virtual Reality Induced Analgesia for Nasal Procedures

NCT06812676 | Completed

• 1 other identifier: Virtual Reality
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In-office nasal procedures can cause pain and discomfort to otolaryngology patients. While local anesthesia is the mainstay choice for main management, patients may have allergies or contraindications to the anesthetic agents used. Moreover, some procedures may not require it, or patients may benefit from additional pain management techniques. The immersive experience of Virtual Reality (VR) could benefit those patients by utilizing visual stimuli to reduce pain perception in the body. This study aims to investigate the efficacy of VR for pain management, and to assess the overall satisfaction of patients. If proven effective, VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinic.

Conditions

Sinus Disease; Rhinitis; Turbinate; Hypertrophy Mucous Membrane; Deviated Nasal Septum Acquired; Deviated Nasal Septum - Congenital

Keywords

Virtual Reality; Nasal Procedures; Nasal Endoscopy; Otolaryngology; Pain Management; Non-pharmacological Intervention; Quality of Care

Outcome Measures

Primary Outcomes (1)

• Pain improvement

  VR arm will experience less pain. VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinics, Pain scores will be measured using the Numeric Rating Pain

  Immediately upon rhinoscopy

Secondary Outcomes (2)

• Patient satisfaction

  Immediately upon rhinoscopy

• patient willingness to use VR in future procedures

  Immediately upon rhinoscopy

Study Arms (2)

VR Arm

EXPERIMENTAL

The VR group will wear the VR

Device: Virtual Reality Goggles

Standard of care Arm

NO INTERVENTION

patients will receive the standard of care

Interventions

Virtual Reality Goggles DEVICE

The VR group will be given a VR headset to wear during the nasal endoscopic procedure at the clinic.

VR Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18-70 years old.
• Both genders.
• Scheduled for a nasal procedure using a 0-degree nasal endoscope.
• Procedure performed by consultant-level rhinologists blinded to the study group assignment (VR or control group).

You may not qualify if:

• History of significant nasal pathology (e.g. ciliary dyskinesia).
• Pregnancy or breastfeeding.
• Known neurological conditions that may affect pain perception or reported history of low pain threshold.
• Inability to understand or follow study procedures due to language barrier or cognitive impairment.
• Pre-existing psychiatric disorders.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Paranasal Sinus Diseases; Rhinitis; Agnosia

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients will be given a VR headset to wear during the nasal endoscopic procedure at the clinic.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: July 17, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-12

Locations

SA (1)