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Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery

Primary Purpose

Anxiety, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality Software
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring virtual reality (VR), anxiety, colorectal cancer, surgery

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed of colorectal cancer requiring elective surgery.
  • American Society of Anesthesiologists (ASA) I - III.
  • No surgical history.
  • Surgical procedure programmed in the next 6 months.

Exclusion Criteria:

  • Neurologic deficits.
  • Visual disorder.
  • Neuro-psychiatric disorder.
  • Use of neuro-psychiatric drugs.
  • Non-sphincter-preserving surgery.

Sites / Locations

  • Victor Turrado-Rodriguez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control

Arm Description

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.

Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease.

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory (STAI)
Change from Baseline Anxiety STAI scale to STAI scale the day previous to the surgery. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
Hospital Anxiety and Depression Scale (HAD)
Change from Baseline Anxiety HAD to HAD scale the day previous to the surgery. The total score for the HADS-A can range from 0 to 21. The following guidelines are recommended for the interpretation of scores: 0-7 for normal or no anxiety, 8-10 for mild anxiety, 11-14 for moderate anxiety, and 12-21 for severe anxiety.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2019
Last Updated
February 13, 2020
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04058600
Brief Title
Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery
Official Title
Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective controlled randomized interventional study comparing the effects of the preoperative exposure to a virtual reality software versus not exposure in 126 patients with colorectal cancer. Patients will be divided in two randomized groups, each of them of 63 patients. The hypothesis of the study is that gradual exposure to the hospital environment using a virtual reality software is effective to reduce preoperative anxiety. 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).
Detailed Description
Colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in Spain it is the first in incidence and prevalence, accounting for 15% of all neoplasias according to World Health Organization (WHO). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Colorectal Cancer
Keywords
virtual reality (VR), anxiety, colorectal cancer, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center prospective randomized two arms study
Masking
None (Open Label)
Masking Description
No masking.
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Software
Intervention Description
Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
Change from Baseline Anxiety STAI scale to STAI scale the day previous to the surgery. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
Time Frame
1 day prior to surgical intervention
Title
Hospital Anxiety and Depression Scale (HAD)
Description
Change from Baseline Anxiety HAD to HAD scale the day previous to the surgery. The total score for the HADS-A can range from 0 to 21. The following guidelines are recommended for the interpretation of scores: 0-7 for normal or no anxiety, 8-10 for mild anxiety, 11-14 for moderate anxiety, and 12-21 for severe anxiety.
Time Frame
1 day prior to surgical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed of colorectal cancer requiring elective surgery. American Society of Anesthesiologists (ASA) I - III. No surgical history. Surgical procedure programmed in the next 6 months. Exclusion Criteria: Neurologic deficits. Visual disorder. Neuro-psychiatric disorder. Use of neuro-psychiatric drugs. Non-sphincter-preserving surgery.
Facility Information:
Facility Name
Victor Turrado-Rodriguez
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) data will not be available to other researchers. The study protocol and the global data will be available in the written paper.
Citations:
PubMed Identifier
19697827
Citation
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.
Results Reference
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PubMed Identifier
22500906
Citation
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.
Results Reference
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PubMed Identifier
28663628
Citation
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.
Results Reference
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PubMed Identifier
19466349
Citation
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.
Results Reference
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PubMed Identifier
19534368
Citation
Jafar MF, Khan FA. Frequency of preoperative anxiety in Pakistani surgical patients. J Pak Med Assoc. 2009 Jun;59(6):359-63.
Results Reference
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PubMed Identifier
25004285
Citation
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.
Results Reference
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PubMed Identifier
27746541
Citation
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.
Results Reference
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PubMed Identifier
28893727
Citation
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.
Results Reference
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PubMed Identifier
27254400
Citation
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.
Results Reference
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Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery

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