Virtual Reality for Post Operative Pain (VRppain)

Babes-Bolyai University

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Device: Virtual Reality intervention - Oculus Rift HD

Study type: Interventional

Funder types: Other

Identifiers

NCT03776344

7150

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality intervention - Oculus Rift HD

Non-VR condition (Standard of Care)

No Intervention group

Description:

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.