Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
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|ClinicalTrials.gov Identifier: NCT01570725|
Recruitment Status : Withdrawn (Difficulty in recruiting the selected subjects)
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
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|
|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|
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.
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.
- 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
- 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
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): NCT01570725
|Regional Hospital No. 25 of the IMSS|
|Mexico City, Mexico|
|Study Director:||Giuseppe Riva, PHD||Istituto Auxologico Italiano|