Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Virtual reality exposure
* Behavioral: Music only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients who undergo ambulatory surgical operations and sign informed consent Exclusion Criteria: death or blind patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment. | Behavioral: Virtual reality exposure<br>* 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.<br>|
| Experimental: 2<br>Exposure to relaxing music. The music will be selected between classical music tunes. | Behavioral: Music only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological measure of anxiety (VAS-A) | Change from baseline in the level of anxiety | One day before operation; one hour after operation; one week after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological parameter (heart rate) | Change from baseline in the heart rate | One day before operation; one hour after operation; one week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immersive virtual reality, e-health, surgery, anxiety, relaxation, Patients who undergo ambulatory surgical operations