Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
Primary Purpose
Anxiety
Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Virtual reality exposure
Music only
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Immersive virtual reality, e-health, surgery, anxiety, relaxation, Patients who undergo ambulatory surgical operations
Eligibility Criteria
Inclusion Criteria:
- all patients who undergo ambulatory surgical operations and sign informed consent
Exclusion Criteria:
- death or blind patients
Sites / Locations
- Regional Hospital No. 25 of the IMSS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.
Exposure to relaxing music. The music will be selected between classical music tunes.
Outcomes
Primary Outcome Measures
Psychological measure of anxiety (VAS-A)
Change from baseline in the level of anxiety
Secondary Outcome Measures
Physiological parameter (heart rate)
Change from baseline in the heart rate
Full Information
NCT ID
NCT01570725
First Posted
February 22, 2009
Last Updated
April 2, 2012
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT01570725
Brief Title
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations
Acronym
VRSurg
Official Title
A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting the selected subjects
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.
Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Immersive virtual reality, e-health, surgery, anxiety, relaxation, Patients who undergo ambulatory surgical operations
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.
Arm Title
2
Arm Type
Experimental
Arm Description
Exposure to relaxing music. The music will be selected between classical music tunes.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality exposure
Intervention Description
The Green Valley, a non interactive, relaxing environment showing a mountain landscape around a calm lake is presented to the patient together with the relaxing music and soft sounds (birds' songs, the water flowing, etc). Having the impression of walking around the lake, patients can observe the nature and virtually seat on a comfortable deck chair, in order to become easily relaxed.
Patients were exposed to the virtual environment for the entire length of the operation.
Intervention Type
Behavioral
Intervention Name(s)
Music only
Intervention Description
A relaxing music and nature sounds have been used to provide a calm atmosphere and reduce stress. In the Music group it was provided to the patients through earphones with no visual stimulation.
Primary Outcome Measure Information:
Title
Psychological measure of anxiety (VAS-A)
Description
Change from baseline in the level of anxiety
Time Frame
One day before operation; one hour after operation; one week after operation
Secondary Outcome Measure Information:
Title
Physiological parameter (heart rate)
Description
Change from baseline in the heart rate
Time Frame
One day before operation; one hour after operation; one week after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients who undergo ambulatory surgical operations and sign informed consent
Exclusion Criteria:
death or blind patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Riva, PHD
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Study Director
Facility Information:
Facility Name
Regional Hospital No. 25 of the IMSS
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations
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