The Effectiveness of Immersive Virtual Reality as a Pain Control Modality After Hip Arthroscopy

NCT05868369 | Completed FDA Device

• 1 other identifier: STUDY00002535
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The purpose of the research is to assess the efficacy of postoperative immersive virtual reality (iVR) compared to a standard multimodal pain regimen including opioids and a local block on acute postoperative pain management following hip arthroscopy
2. 2.The primary research procedures are medical record review for demographic information, head-mounted immersive virtual reality experience in PACU, and pre-operative and post-operative surveys
3. 3.The study will enroll adult patients of all ages undergoing elective hip arthroscopy procedures for any diagnosis

Conditions

Hip Pain Chronic

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• Pain visual analog scale (VAS)

  subjects rate their pain from 0-10, 0 being the least and 10 being the worst.

  one time at Day 1 post operative

Secondary Outcomes (2)

• Anxiety PACU questionnaire

  one time Day 1 of surgery post-op

• Nausea PACU Questionnaire

  one time Day 1 of surgery post-op

Study Arms (2)

Standard regimen +iVR Group

EXPERIMENTAL

postoperative iVR therapy in addition to the standard multimodal pain regimen (including a preoperative local field block

Device: iVR Group; Drug: Standard pain management regimen

Standard regimen

ACTIVE COMPARATOR

hip arthroscopy patients who receive only the standard regimen (including field block) in the acute postoperative ambulatory setting

Drug: Standard pain management regimen

Interventions

iVR Group DEVICE

On the day of surgery, the iVR group will receive a 30-minute sessions or "dose" of iVR therapy in the ambulatory post-anesthesia care unit (PACU) during their stay. The three distraction-based or skills-based iVR modules will consist of either 1) Mindful Escape; 2) Empowered Breathing; or 3) Relaxation videos. The iVR group will be sub-randomized into receiving only one of the three types of modules. The modules will start approximately 30 minutes upon arriving in PACU and will last approximately 30 minutes.

Standard regimen +iVR Group

Standard pain management regimen DRUG

In the ambulatory post-anesthesia care unit (PACU) during their stay with have standard postoperative pain protocol (including a pre-operative local field block).

Standard regimen; Standard regimen +iVR Group

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older with hip pathology
• Failed non-operative treatment of hip pathology
• Undergoing primary, elective and isolated hip arthroscopy for their hip pathology
• Complete pre-operative and post-operative questionnaires

You may not qualify if:

• Minors (17 years of age and younger)
• Traumatic injuries undergoing emergent surgery
• Undergoing revision hip arthroscopic surgery
• Do not complete pre-operative and post-operative questionnaires
• Patients not able to undergo elective surgery
• Pregnant women
• Prisoners
• Patients with conditions that interfere with VR usage including: history of seizure or epilepsy, facial injury precluding safe placement of headset, visual impairment impacting ability to visualize VR images, hearing impairment impacting ability to follow audio instructions

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Kerlan Jobe

Los Angeles, California, 90045, United States

Location

Study Officials

• Karen Ladnier, MS

  Cedar -Sinai Kerlan jobe orthopedic institute

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: May 22, 2023
• Study Start: November 1, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)