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

Istituto Auxologico Italiano

Status: Withdrawn

Conditions: Anxiety

Treatments: Behavioral: Music only; Behavioral: Virtual reality exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01570725

VR01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• death or blind patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Behavioral: Virtual reality exposure

2

Experimental group

Description:

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

Treatment:

Behavioral: Music only