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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Virtual reality exposure; Behavioral: Music only

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Regional Hospital No. 25 of the IMSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• death or blind patients

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Study Director: Giuseppe Riva, PHD, Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 22, 2009
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 2, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: surgery; anxiety; relaxation; e-health; Immersive virtual reality; Patients who undergo ambulatory surgical operations
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: VR01