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Virtual Reality for Post Operative Pain (VRppain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776344
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Raluca Georgescu, Babes-Bolyai University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE October 10, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • Pain intensity [ Time Frame: immediately before intervention; 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, during the intervention ]
    Skin conductance response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • 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: immediately before intervention; 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality for Post Operative Pain
Official Title  ICMJE Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Virtual Reality intervention - Oculus Rift HD
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2020)		 62
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)		 60
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03776344
Other Study ID Numbers  ICMJE 7150
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected data will be shared in an anonymized manner.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After the manuscript will be published.
Current Responsible Party Raluca Georgescu, Babes-Bolyai University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Babes-Bolyai University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Babes-Bolyai University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP