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Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01570725
Acronym
VRSurg
Enrollment
0
Registered
2012-04-04
Start date
2008-10-31
Completion date
2011-02-28
Last updated
2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

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

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.

Interventions

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.

BEHAVIORALMusic 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.

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* death or blind patients

Design outcomes

Primary

MeasureTime frameDescription
Psychological measure of anxiety (VAS-A)One day before operation; one hour after operation; one week after operationChange from baseline in the level of anxiety

Secondary

MeasureTime frameDescription
Physiological parameter (heart rate)One day before operation; one hour after operation; one week after operationChange from baseline in the heart rate

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026