NCT04058600

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

June 7, 2019

Last Update Submit

February 13, 2020

Conditions

AnxietyColorectal Cancer

Keywords

virtual reality (VR)anxietycolorectal cancersurgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 day prior to surgical intervention

  • 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.

    1 day prior to surgical intervention

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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.

Behavioral: Virtual Reality Software

Control

NO INTERVENTION

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

Interventions

Virtual Reality SoftwareBEHAVIORAL

Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.

Virtual Reality

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victor Turrado-Rodriguez

Barcelona, 08036, Spain

Location

Related Publications (9)

  • 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.

    PMID: 19697827BACKGROUND

  • 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.

    PMID: 22500906BACKGROUND

  • 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.

    PMID: 28663628BACKGROUND

  • 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.

    PMID: 19466349BACKGROUND

  • Jafar MF, Khan FA. Frequency of preoperative anxiety in Pakistani surgical patients. J Pak Med Assoc. 2009 Jun;59(6):359-63.

    PMID: 19534368BACKGROUND

  • 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.

    PMID: 25004285BACKGROUND

  • 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.

    PMID: 27746541BACKGROUND

  • 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.

    PMID: 28893727BACKGROUND

  • 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.

    PMID: 27254400BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersColorectal Neoplasms

Condition Hierarchy (Ancestors)

Mental DisordersIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single center prospective randomized two arms study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gastrointestinal Surgery Department

Study Record Dates

First Submitted

June 7, 2019

First Posted

August 15, 2019

Study Start

April 11, 2018

Primary Completion

February 11, 2020

Study Completion

February 12, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)