Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

NCT ID: NCT01570725

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.

Group Type: EXPERIMENTAL

Virtual reality exposure

Intervention Type: BEHAVIORAL

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.

2

Exposure to relaxing music. The music will be selected between classical music tunes.

Group Type: EXPERIMENTAL

Music only

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• death or blind patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Riva, PHD

Role: STUDY_DIRECTOR

Istituto Auxologico Italiano

Locations

Regional Hospital No. 25 of the IMSS

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

VR01

Identifier Type: -

Identifier Source: org_study_id