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

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting the selected subjects)
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT01570725
First received: February 22, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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 Intervention
Anxiety
Behavioral: Virtual reality exposure
Behavioral: Music only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Istituto Auxologico Italiano:

Primary Outcome Measures:
  • Psychological measure of anxiety (VAS-A) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ]
    Change from baseline in the level of anxiety


Secondary Outcome Measures:
  • Physiological parameter (heart rate) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ]
    Change from baseline in the heart rate


Enrollment: 0
Study Start Date: October 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • death or blind patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570725

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

No publications provided

Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT01570725     History of Changes
Other Study ID Numbers: VR01
Study First Received: February 22, 2009
Last Updated: April 2, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Istituto Auxologico Italiano:
Immersive virtual reality
e-health
surgery
anxiety
relaxation
Patients who undergo ambulatory surgical operations

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014