Virtual Reality Distraction for Reduction

Postoperative Pain Clinical Trial

Official title:

Virtual Reality Distraction for Reduction in Acute Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416555
• Other study ID #: 19-769
• Secondary ID: R44DA049640
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: May 3, 2022

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.

Description:

Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 3, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology Physical Status 1-3;

• Scheduled for elective, primary total hip arthroplasty;

• Anticipated hospitalization of at least 1 night;

• Expected to require parenteral opioids for postoperative pain;

• Able to use IV PCA systems.

Exclusion criteria:

• History of chronic pain or care by a pain management specialist;

• Use of more than 30 mg/day of oral oxycodone (or equivalent);

• Greater than 12 weeks of current and continued opioid use;

• History of seizures, epilepsy, motion sickness, stroke, dementia;

• Non-English speaking;

• Women who are pregnant or breastfeeding;

• History of substance use disorder.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Placebo comparator: VR googles and the non reality experience
parallel assignment (this arm will receive a static presentation in the same device)
• Active Comparator: VR googles and the real VR program to enter act with and experience
Parallel assignment (this arm will receive the full immersive virtual reality experience

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (Numerical Rating Scale)	The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.	From the end of surgery until 48 hours after surgery or discharge, whichever comes first
Secondary	Total Opioid Consumption	The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).	End of surgery to 72 hours after surgery.
Secondary	Time Weighted Average Pain Score	Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures.	End of surgery to 48 hours after surgery
Secondary	Perception of Video System Usability	Patient's perception of video system usability was assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.	Once between last intervention time and hospital discharge (up to 8 days after end of surgery)
Secondary	Post Discharge Analgesia.	Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.	One week (7 days) after hospital discharge