Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

Not Applicable

Withdrawn

• Conditions: Anxiety
• Interventions: Behavioral: Virtual reality exposure; Behavioral: Music only

• Registration Number: NCT01570725
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-22
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-02
• Last Update Submitted: 2012-04-02
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• death or blind patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Virtual reality exposure	Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.
2	Music only	Exposure to relaxing music. The music will be selected between classical music tunes.

Primary Outcome Measures

Name	Time	Method
Psychological measure of anxiety (VAS-A)	One day before operation; one hour after operation; one week after operation	Change from baseline in the level of anxiety

Secondary Outcome Measures

Name	Time	Method
Physiological parameter (heart rate)	One day before operation; one hour after operation; one week after operation	Change from baseline in the heart rate

Trial Locations

Locations (1)

Regional Hospital No. 25 of the IMSS; 🇲🇽 Mexico City, Mexico