Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting the selected subjects)
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT01570725
First received: February 22, 2009
Last updated: April 2, 2012
Last verified: April 2012

February 22, 2009
April 2, 2012
October 2008
February 2011   (final data collection date for primary outcome measure)
Psychological measure of anxiety (VAS-A) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ]
Change from baseline in the level of anxiety
Same as current
Complete list of historical versions of study NCT01570725 on ClinicalTrials.gov Archive Site
Physiological parameter (heart rate) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ]
Change from baseline in the heart rate
Same as current
Not Provided
Not Provided
 
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations
A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Anxiety
  • Behavioral: Virtual reality exposure

    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.

  • Behavioral: Music only
    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.
  • Experimental: 1
    Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.
    Intervention: Behavioral: Virtual reality exposure
  • Experimental: 2
    Exposure to relaxing music. The music will be selected between classical music tunes.
    Intervention: Behavioral: Music only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients who undergo ambulatory surgical operations and sign informed consent

Exclusion Criteria:

  • death or blind patients
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01570725
VR01
Yes
Istituto Auxologico Italiano
Istituto Auxologico Italiano
Not Provided
Study Director: Giuseppe Riva, PHD Istituto Auxologico Italiano
Istituto Auxologico Italiano
April 2012

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