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

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. Identifier: NCT01570725
Recruitment Status : Withdrawn (Difficulty in recruiting the selected subjects)
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Information provided by (Responsible Party):
Istituto Auxologico Italiano

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Virtual reality exposure Behavioral: Music only Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study
Study Start Date : October 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.
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.

Experimental: 2
Exposure to relaxing music. The music will be selected between classical music tunes.
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.

Primary Outcome Measures :
  1. Psychological measure of anxiety (VAS-A) [ Time Frame: One day before operation; one hour after operation; one week after operation ]
    Change from baseline in the level of anxiety

Secondary Outcome Measures :
  1. Physiological parameter (heart rate) [ Time Frame: One day before operation; one hour after operation; one week after operation ]
    Change from baseline in the heart rate

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • death or blind patients

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 identifier (NCT number): NCT01570725

Regional Hospital No. 25 of the IMSS
Mexico City, Mexico
Sponsors and Collaborators
Istituto Auxologico Italiano
Study Director: Giuseppe Riva, PHD Istituto Auxologico Italiano

Responsible Party: Istituto Auxologico Italiano Identifier: NCT01570725     History of Changes
Other Study ID Numbers: VR01
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Istituto Auxologico Italiano:
Immersive virtual reality
Patients who undergo ambulatory surgical operations

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders