Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
| Tracking Information | |||||
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| First Received Date ICMJE | February 22, 2009 | ||||
| Last Updated Date | April 2, 2012 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Psychological measure of anxiety (VAS-A) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ] Change from baseline in the level of anxiety |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01570725 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Physiological parameter (heart rate) [ Time Frame: One day before operation; one hour after operation; one week after operation ] [ Designated as safety issue: No ] Change from baseline in the heart rate |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations | ||||
| Official Title ICMJE | A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Anxiety | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01570725 | ||||
| Other Study ID Numbers ICMJE | VR01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Istituto Auxologico Italiano | ||||
| Study Sponsor ICMJE | Istituto Auxologico Italiano | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Istituto Auxologico Italiano | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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