Virtual Reality for Post Operative Pain (VRppain)

Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial

Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: Virtual Reality intervention - Oculus Rift HD

Detailed Description

While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., & Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Municipal Hospital of Cluj-Napoca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with varicose vein, hernia repair or gallbladder surgery
• Patient in the acute care units, 1-3 days following surgery.
• Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.

Exclusion Criteria:

• Non-Romanian speaking patients.
• Age > 18 years and < 65 years.
• Patients with neoplastic pathologies.
• Patients with history of motion sickness.
• Patients with visual impairment.
• Patients with severe/profound cognitive impairments measured with Six-item Cognitive Impairment Test (6CIT).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures.	Device: Virtual Reality intervention - Oculus Rift HD; During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.
No Intervention: Non-VR condition (Standard of Care); Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.	Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Pain intensity	Skin conductance response	5 minutes before intervention (baseline)
Pain intensity	Skin conductance response	15 minutes - During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the intervention	Patient Satisfaction Survey	Immediately following intervention
Presence in the VR environment	Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention	Immediately following intervention
Simulator Sickness	Simulator Sickness Questionnaire	Immediately following intervention
Relaxation	Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.	Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
Time thinking about pain	Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time	immediately following intervention

Collaborators and Investigators

• Sponsor: Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 7150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data will be shared in an anonymized manner.
• IPD Sharing Time Frame: After the manuscript will be published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No