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Virtual Reality for Post Operative Pain (VRppain)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
Virtual Reality intervention - Oculus Rift HD
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Municipal Hospital of Cluj-Napoca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Non-VR condition (Standard of Care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
Pain intensity
Skin conductance response
Pain intensity
Skin conductance response

Secondary Outcome Measures

Satisfaction with the intervention
Patient Satisfaction Survey
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
Simulator Sickness
Simulator Sickness Questionnaire
Relaxation
Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.
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

Full Information

First Posted
December 12, 2018
Last Updated
January 13, 2020
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT03776344
Brief Title
Virtual Reality for Post Operative Pain
Acronym
VRppain
Official Title
Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
We tested the efficacy of a VR environment in the treatment of pain after surgery.
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-VR condition (Standard of Care)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality intervention - Oculus Rift HD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
Time Frame
Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Title
Pain intensity
Description
Skin conductance response
Time Frame
5 minutes before intervention (baseline)
Title
Pain intensity
Description
Skin conductance response
Time Frame
15 minutes - During the intervention
Secondary Outcome Measure Information:
Title
Satisfaction with the intervention
Description
Patient Satisfaction Survey
Time Frame
Immediately following intervention
Title
Presence in the VR environment
Description
Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention
Time Frame
Immediately following intervention
Title
Simulator Sickness
Description
Simulator Sickness Questionnaire
Time Frame
Immediately following intervention
Title
Relaxation
Description
Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.
Time Frame
Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
Title
Time thinking about pain
Description
Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time
Time Frame
immediately following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Municipal Hospital of Cluj-Napoca
City
Cluj-Napoca
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data will be shared in an anonymized manner.
IPD Sharing Time Frame
After the manuscript will be published.

Learn more about this trial

Virtual Reality for Post Operative Pain

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