AnxietyNCT04058600
Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery
A study testing Virtual Reality Software in people with Anxiety and Colorectal Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anxiety, Colorectal Cancer
- What is being tested?
- Virtual Reality Software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2018to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neurologic deficits.
- Visual disorder.
- Neuro-psychiatric disorder.
- Use of neuro-psychiatric drugs.
- Non-sphincter-preserving surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain
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).
Read the 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.
- Conditions
- Anxiety, Colorectal Cancer
- Being tested
- Virtual Reality Software
- Keywords
- virtual reality (VR), anxiety, colorectal cancer, surgery
- Medical subject headings
- Anxiety Disorders, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SoftwareBehavioural
Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day prior to surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start11 Apr 2018
- Primary completion11 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center prospective randomized two arms study
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio M Lacy, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058600
- Sponsor's protocol ID
- HCB/2018/0290 CIF-G-08431173
- Status last verified
- Feb 2020
- First submitted
- 7 Jun 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 19697827Matthias 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.
PubMed 22500906Tulgar 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.
PubMed 28663628Marcolino 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.
PubMed 19466349Jafar MF, Khan FA. Frequency of preoperative anxiety in Pakistani surgical patients. J Pak Med Assoc. 2009 Jun;59(6):359-63.
PubMed 19534368Santos 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.
PubMed 25004285Kaur 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.
PubMed 27746541Eijlers 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.
PubMed 28893727Ortuno-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.
PubMed 27254400
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain
- ClinicalTrials.gov ID
- NCT04058600
- Acronym / sponsor ID
- HCB/2018/0290 CIF-G-08431173
- Conditions
- Anxiety, Colorectal Cancer
- Keywords
- virtual reality (VR), anxiety, colorectal cancer, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center prospective randomized two arms study
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Reality SoftwareThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Neurologic deficits.
- Visual disorder.
- Neuro-psychiatric disorder.
- Use of neuro-psychiatric drugs.
- Non-sphincter-preserving surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality SoftwarePatients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room. | Behavioural | Virtual Reality |
Primary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: 1 day prior to surgical intervention
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)
Time frame: 1 day prior to surgical intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 19697827Romanik 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.
- Background: PubMed 22500906Matthias 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.
- Background: PubMed 28663628Tulgar 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.
- Background: PubMed 19466349Marcolino 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.
- Background: PubMed 19534368Jafar MF, Khan FA. Frequency of preoperative anxiety in Pakistani surgical patients. J Pak Med Assoc. 2009 Jun;59(6):359-63.
- Background: PubMed 25004285Santos 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.
- Background: PubMed 27746541Kaur 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.
- Background: PubMed 28893727Eijlers 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.
- Background: PubMed 27254400Ortuno-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Software in people with Anxiety and Colorectal Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: 1 day prior to surgical intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058600, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.