Virtual Reality for Post Operative Pain

NCT ID: NCT03776344

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-09-30

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Virtual Reality

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.

Group Type: EXPERIMENTAL

Virtual Reality intervention - Oculus Rift HD

Intervention Type: DEVICE

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.

Non-VR condition (Standard of Care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Babes-Bolyai University

OTHER

Sponsor Role: lead

Responsible Party

Raluca Georgescu

Phd student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Municipal Hospital of Cluj-Napoca

Cluj-Napoca, , Romania

Countries

Romania

Other Identifiers

7150

Identifier Type: -

Identifier Source: org_study_id