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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
Sponsor:
Information provided by (Responsible Party):
Raluca Georgescu, Babes-Bolyai University

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Virtual Reality intervention - Oculus Rift HD Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Pain intensity [ Time Frame: 5 minutes before intervention (baseline) ]
    Skin conductance response

  3. Pain intensity [ Time Frame: 15 minutes - During the intervention ]
    Skin conductance response


Secondary Outcome Measures :
  1. Satisfaction with the intervention [ Time Frame: Immediately following intervention ]
    Patient Satisfaction Survey

  2. 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

  3. Simulator Sickness [ Time Frame: Immediately following intervention ]
    Simulator Sickness Questionnaire

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Romania
Municipal Hospital of Cluj-Napoca
Cluj-Napoca, Romania
Sponsors and Collaborators
Babes-Bolyai University
More Information
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Responsible Party: Raluca Georgescu, Phd student, Babes-Bolyai University
ClinicalTrials.gov Identifier: NCT03776344    
Other Study ID Numbers: 7150
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data will be shared in an anonymized manner.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After the manuscript will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations