Pain, Postoperative
Conditions
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.
Interventions
DEVICEVirtual 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.
Sponsors
Babes-Bolyai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
As we had two groups in which one used a device for ensuring the masking the entire procedure was conducted in a separate room.
Intervention model description
We tested the efficacy of a VR environment in the treatment of pain after surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention) | Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the intervention | Immediately following intervention | Patient Satisfaction Survey |
| Presence in the VR environment | Immediately following intervention | Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention |
| Simulator Sickness | Immediately following intervention | Simulator Sickness Questionnaire |
| Relaxation | Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention) | Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed. |
| Time thinking about pain | immediately following intervention | Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time |
Countries
Romania
Outcome results
None listed