Virtual Reality for Post Operative Pain

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

Detailed Description
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Virtual Reality intervention - Oculus Rift HD


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We tested the efficacy of a VR environment in the treatment of pain after surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>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<br>* 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.<br>|
| No Intervention: Non-VR condition (Standard of Care)<br>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?
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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 |