Virtual Reality for Post Operative Pain

Pain, Postoperative Clinical Trial

— VRppain  

Official title:

Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776344
• Other study ID #: 7150
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Romania	Municipal Hospital of Cluj-Napoca	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.	Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Primary	Pain intensity	Skin conductance response	5 minutes before intervention (baseline)
Primary	Pain intensity	Skin conductance response	15 minutes - During the intervention
Secondary	Satisfaction with the intervention	Patient Satisfaction Survey	Immediately following intervention
Secondary	Presence in the VR environment	Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention	Immediately following intervention
Secondary	Simulator Sickness	Simulator Sickness Questionnaire	Immediately following intervention
Secondary	Relaxation	Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.	Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
Secondary	Time thinking about pain	Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time	immediately following intervention