Virtual Reality for Post Operative Pain (VRppain)
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|ClinicalTrials.gov Identifier: NCT03776344|
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Device: Virtual Reality intervention - Oculus Rift HD||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We tested the efficacy of a VR environment in the treatment of pain after surgery.|
|Masking:||Double (Participant, Care Provider)|
|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.|
|Official Title:||Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial|
|Actual Study Start Date :||October 10, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||September 30, 2019|
Experimental: 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.
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.
No Intervention: 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.
- Pain intensity [ Time Frame: 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.
- Pain intensity [ Time Frame: 5 minutes before intervention (baseline) ]Skin conductance response
- Pain intensity [ Time Frame: 15 minutes - During the intervention ]Skin conductance response
- Satisfaction with the intervention [ Time Frame: Immediately following intervention ]Patient Satisfaction Survey
- Presence in the VR environment [ Time Frame: 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 [ Time Frame: Immediately following intervention ]Simulator Sickness Questionnaire
- Relaxation [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776344
|Municipal Hospital of Cluj-Napoca|