Skip to main content
Clinical Trials/NCT01570725
NCT01570725
Withdrawn
Not Applicable

A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study

Istituto Auxologico Italiano1 site in 1 countryOctober 2008
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Istituto Auxologico Italiano
Locations
1
Primary Endpoint
Psychological measure of anxiety (VAS-A)
Status
Withdrawn
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
February 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • death or blind patients

Outcomes

Primary Outcomes

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 Outcomes

  • Physiological parameter (heart rate)(One day before operation; one hour after operation; one week after operation)

Study Sites (1)

Loading locations...

Similar Trials