Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

NCT01570725 | Withdrawn DMC

• 1 other identifier: VR01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Immersive virtual reality; e-health; surgery; anxiety; relaxation; Patients who undergo ambulatory surgical operations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physiological parameter (heart rate)

  One day before operation; one hour after operation; one week after operation

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Virtual reality exposure

2

EXPERIMENTAL

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

Behavioral: Music only

Interventions

Virtual reality exposure 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.

1

Music only 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.

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• death or blind patients

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Regional Hospital No. 25 of the IMSS

Mexico City, Mexico

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Giuseppe Riva, PHD

  Istituto Auxologico Italiano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2009
• First Posted: April 4, 2012
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

ME (1)