Clinical trial NCT03776344: Virtual Reality for Post Operative Pain
Official title: Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We tested the efficacy of a VR environment in the treatment of pain after surgery.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Pain intensity
timeFrame: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
measure: Pain intensity
timeFrame: 5 minutes before intervention (baseline)
measure: Pain intensity
timeFrame: 15 minutes - During the intervention
Secondary outcomes:
measure: Satisfaction with the intervention
timeFrame: Immediately following intervention
measure: Presence in the VR environment
timeFrame: Immediately following intervention
measure: Simulator Sickness
timeFrame: Immediately following intervention
measure: Relaxation
timeFrame: Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
measure: Time thinking about pain
timeFrame: immediately following intervention
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Municipal Hospital of Cluj-Napoca
Study officials:
References: