Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- Babes-Bolyai University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.
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.
Investigators
Raluca Georgescu
Phd student
Babes-Bolyai University
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 15 minutes - During the intervention
Skin conductance response
Secondary Outcomes
- Satisfaction with the intervention(Immediately following intervention)
- Presence in the VR environment(Immediately following intervention)
- Simulator Sickness(Immediately following intervention)
- Relaxation(Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention))
- Time thinking about pain(immediately following intervention)