Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery
NCT ID: NCT04058600
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2018-04-11
2020-02-12
Brief Summary
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The main variable is the level of anxiety in patients undergoing colorectal cancer surgery. It will be measured using State-Trait Anxiety Inventory Scale (STAI-S) and the Hospital Anxiety and Depression Scale (HADS).
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Detailed Description
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The incidence of preoperative anxiety in patients undergoing elective surgery is high (60% - 76%). There are many causes for this: anticipation of postoperative pain, loss of independence, separation from the family, fear to the surgical procedure or to severe complications or even death. The incidence of preoperative anxiety varies according to age, sex, educational leve, previous exposure to surgical interventions and the expected impact of the surgical procedure in global quality of life.
Patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and a higher rate of perioperative complications due to a release of catecholamines, increase on the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc.
Gradual exposition is considered an effective way of reducing anxiety. It has been demonstrated that anxiety is decreased in patients with history of surgical interventions, and thus the experience is experimented as an adaptive process. Virtual reality gives the opportunity to experience each of the steps of the hospital stay in a realistic environment.
The hypothesis of this study is that gradual exposure to the hospital environment using virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing colorectal cancer surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Virtual Reality
The patients will be exposed to a virtual reality software that simulates the environment of the hospital, from admission to the operating room and the recovery room.
Virtual Reality Software
Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
Control
Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease.
No interventions assigned to this group
Interventions
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Virtual Reality Software
Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) I - III.
* No surgical history.
* Surgical procedure programmed in the next 6 months.
Exclusion Criteria
* Visual disorder.
* Neuro-psychiatric disorder.
* Use of neuro-psychiatric drugs.
* Non-sphincter-preserving surgery.
18 Years
99 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Antonio M Lacy
Chief of Gastrointestinal Surgery Department
Locations
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Victor Turrado-Rodriguez
Barcelona, , Spain
Countries
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References
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Romanik W, Kanski A, Soluch P, Szymanska O. [Preoperative anxiety assessed by questionnaires and patient declarations]. Anestezjol Intens Ter. 2009 Apr-Jun;41(2):94-9. Polish.
Matthias AT, Samarasekera DN. Preoperative anxiety in surgical patients - experience of a single unit. Acta Anaesthesiol Taiwan. 2012 Mar;50(1):3-6. doi: 10.1016/j.aat.2012.02.004. Epub 2012 Mar 30.
Tulgar S, Boga I, Piroglu MD, Ates NG, Bombaci E, Can T, Selvi O, Tas Z, Kose HC. Preoperative Anxiety before Spinal Anesthesia: Does Internet-based Visual Information/Multimedia Research Decrease Anxiety and Information Desire? A Prospective Multicentered Study. Anesth Essays Res. 2017 Apr-Jun;11(2):390-396. doi: 10.4103/0259-1162.206278.
Marcolino JA, Suzuki FM, Alli LA, Gozzani JL, Mathias LA. [Measurement of anxiety and depression in preoperative patients. Comparative study.]. Rev Bras Anestesiol. 2007 Apr;57(2):157-66. doi: 10.1590/s0034-70942007000200004. Portuguese.
Jafar MF, Khan FA. Frequency of preoperative anxiety in Pakistani surgical patients. J Pak Med Assoc. 2009 Jun;59(6):359-63.
Santos LJ, Garcia JB, Pacheco JS, Vieira EB, Santos AM. Quality of life, pain, anxiety and depression in patients surgically treated with cancer of rectum. Arq Bras Cir Dig. 2014 Apr-Jun;27(2):96-100. doi: 10.1590/s0102-67202014000200003.
Kaur H, Singh G, Singh A, Sharda G, Aggarwal S. Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety. Anesth Essays Res. 2016 Sep-Dec;10(3):502-507. doi: 10.4103/0259-1162.177187.
Eijlers R, Legerstee JS, Dierckx B, Staals LM, Berghmans J, van der Schroeff MP, Wijnen RM, Utens EM. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617.
Ortuno-Sierra J, Garcia-Velasco L, Inchausti F, Debbane M, Fonseca-Pedrero E. New approaches on the study of the psychometric properties of the STAI. Actas Esp Psiquiatr. 2016 May;44(3):83-92. Epub 2016 May 1.
Other Identifiers
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HCB/2018/0290 CIF-G-08431173
Identifier Type: -
Identifier Source: org_study_id
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