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Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer (VIREA)

Primary Purpose

Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pre-operative use of virtual reality headset
Standard surgery
Post-operative use of virtual reality headset
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Tumor, Malignant focused on measuring colon cancer, anxiety, pain, virtual reality, malignant colon tumor, malignant rectum tumor, virtual reality immersion

Eligibility Criteria

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

Inclusion Criteria: Patients with colorectal cancer (colon or rectum), regardless of oncological stage and neo-adjuvant treatments received, or a colorectal lesion judged as endoscopically unresectable, with indication for surgical management either by laparotomy or laparoscopy Elective surgery Patient ≥ 18 years old Patient affiliated to a social security system or entitled to it Patient who has received full information on the research organization and has given written consent Exclusion Criteria: Complicated tumour (perforation, occlusion) requiring emergency surgery Non-French speaking patient Patient subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Pregnant or breastfeeding woman Patient benefiting from the AME Epilepsy Severe visual or hearing impairment that does not allow the use of headphones Autism spectrum disorder Claustrophobia Confusion Medical history of schizophrenia, schizotypal disorders and delusional disorders, and/or patients requiring treatment with : Neuroleptics (Abilify = Aripiprazole and Abilify Now, Clopixol = Zuclopenthixol, Haldol = Haloperidol and Haldol Decanoas, Largactil = Chlorpromazine, Leponex = Clozapine, Loxapac = Loxapine, Nozinan = Levomepromazine, Risperdal = Risperidone and Xeplion and Trevicta, Solian = Amisulpride, Tercian = Cyamemazine, Tiapridal = Tiapride, Xeroquel = Quetiapine, Zyprexa = Olanzapine and Zypadhera); Thymoregulators (Depakote / Depamide = Valproate de Sodium, Lamictal = Lamotrigine, Tegretol = Carbamazepine, Teralithe = Lithium)

Sites / Locations

  • Hôpital européen Georges-Pompidou AP-HPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immersive reality group

Standard care group

Arm Description

patients receive care according to the usual practices of the department as well as virtual reality. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. Virtual reality headset is put on the day before the operation and in the morning just before going to the operating theatre (only on the morning of the operation for patients hospitalized the same day). The colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number (day and night).

patients are treated according to usual practices of the department and do not have access to virtual reality.

Outcomes

Primary Outcome Measures

Anxiety assessment
Change from State-Trait Anxiety Inventory (STAI-A) scores at D-7 before surgery and at discharge (maximum at day 30 after surgery).

Secondary Outcome Measures

Total painkiller use (opioids and non-opioids) during hospitalization
painkillers and their use are prescribed and referenced in the software used in our department (Dxcare®). Data will be collected every day to obtain daily and total consumption.
Pain assessment
Maximum pain experienced by the patient during the hospital stay using the numerical pain scale (NPS): nurses record patients' pain at least 4 times a day and note it directly in Dxcare® software (NPS 0 = no pain, NPS 10 = maximal pain) .
Total anxiolytic use (benzodiazepines, related hypnotics, hydroxyzine) during hospitalization
Anxiolytics and their use are prescribed and referenced in the software used in our department (Dxcare®). Data will be collected every day to obtain daily and total consumption.
Adverse effects of virtual reality immersion
Main adverse effects expected (nausea, vomiting, vertigo, headaches). Virtual reality sessions will be subject to a medical prescription on the software used in our department (Dxcare®). To validate each session, nurses will have to answer a questionnaire stating session duration, anxiety level before the session, reasons for a potential refusal, tolerance, possible comments on the programs used and number of sessions per day.
Morbidity and mortality
Severe morbidity (Clavien Dindo classification)
Confounding factors of anxiety
Measures of depression (CES-D, Center for Epidemiologic Studies - Depression - French version) and alcohol and tobacco consumption are included. These are indeed confounding factors of anxiety and potential moderating factors of virtual reality's effectiveness.
Morbidity
Transit recovery time

Full Information

First Posted
October 3, 2022
Last Updated
April 14, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
VR 4 GOOD
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1. Study Identification

Unique Protocol Identification Number
NCT05653934
Brief Title
Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer
Acronym
VIREA
Official Title
Virtual Reality Immersion With 360° Virtual Reality Headset to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer: a Randomized Controlled Pilot Trial - VIREA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
VR 4 GOOD

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
In patients operated for colorectal cancer, pain, anxiety and depression are important factors in postoperative rehabilitation. The use of new technologies, as virtual reality immersion, could further improve their postoperative management. To date, no study has evaluated the potential benefits of using virtual reality before and after colorectal cancer surgery. The main objective is to determine if virtual reality can reduce postoperative anxiety in patients undergoing colorectal cancer surgery. To answer this question, the investigators plan to execute a randomized controlled, single-center, open-label, superiority interventional trial. Patients will be randomized into 2 parallel arms: 1 interventional "virtual immersion" arm and 1 "control" arm. Patients with colorectal cancer, regardless of oncological stage, or a colorectal lesion deemed endoscopically unresectable, with an indication for elective surgical management by laparotomy or laparoscopy will be included. For patients in the interventional arm, virtual reality headset is put on the day before the operation and in the morning just before going down to the operating theatre. Colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. This is a purely contemplative mode, lasting maximum 30 minutes. For the control arm, patients are treated according to the usual practices of the department and do not have access to virtual reality. The main purpose is to show a greater decrease in anxiety in the interventional group by measuring the absolute difference between the State-Trait Anxiety Inventory scores before surgery and at discharge.
Detailed Description
The investigators plan to execute a randomized controlled, single-center, open-label, superiority interventional trial. Patients will be randomized into 2 parallel arms: 1 interventional "virtual immersion" arm and 1 "control" arm. Randomization (1:1) will be stratified by cancer type (colon vs rectum). The randomization list will be balanced by small blocks of different sizes, randomly alternated to make it unpredictable. The block sizes will be provided in the final study report. The randomization list will be created by a member of the Digestive and Oncological Surgery department not involved in the study and will be added in REDCap software. Study process: - Preoperative consultation: information, surgery planning, obtaining patient consent, randomization and provision of 2 self-administered questionnaires: State-Trait Anxiety Inventory (STAI A "state" anxiety - French version) and CES-D (Center for Epidemiologic Studies - Depression - French version) to be completed at home. Note: measures of depression (CES-D, Center for Epidemiologic Studies - Depression - French version) and alcohol and tobacco consumption are included. These are indeed confounding factors of anxiety and potential moderating factors of virtual reality's effectiveness. Beginning of the study (7 days before surgery): all patients filled in the self-questionnaires at home and brought them the day of the surgery. For the interventional arm, patients receive care according to the usual practices of the department as well as virtual reality. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. Virtual reality headset is put on the day before the operation and in the morning just before going to the operating theatre (only on the morning of the operation for patients hospitalized the same day). The colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number (day and night). Virtual reality sessions take place in the patient's room in bed or in the armchair on a fixed point, with a maximum duration of 30 minutes. The patient can stop the session at any time. The masks are cleaned before and after each use (Anios® wipes) and brought to the patient by the medical or paramedical staff (nurses only). Virtual reality sessions are prescribed by the medical staff using the software used in the department (Dxcare®). For each session, nurses record the duration of the session, the level of anxiety before the session (numerical scale with a score between 0 and 10), the reasons for a potential refusal, the tolerance and any comments on the programs used. For the control arm: patients are treated according to usual practices of the department and do not have access to virtual reality. End of study: at the end of the hospitalization, the patients fill in the same self-questionnaire State-Trait Anxiety Inventory (STAI A anxiety "state" - French version). In case of prolonged hospitalization for any reason, the end date of study, with the completion of the questionnaire, is set to the 30th postoperative day. No specific post-interventional follow-up is required for this research. The patients included in this study will continue their usual follow-up according to their initial condition and the department's procedures. The main purpose is to show a greater decrease in anxiety in the interventional group by measuring the absolute difference between the State-Trait Anxiety Inventory scores before surgery and at discharge. Sample size calculation: Control group: decrease of 2.55 points (STAI after-STAI before). Intervention group: decrease of 3.1875 points (STAI after-STAI before). With a relative difference of 25% (i.e. a difference of 0.6375 +/- 1.2) between the two groups, for an alpha risk of 5% and a power of 80%, 57 patients per arm are required, i.e. a total of 114 patients. To overcome the missing data risk, a 10% addition of patients was estimated, i.e. 124 patients in total. The main analysis will be an intention-to-treat and per-protocol method. The primary endpoint will be compared between groups by linear regression adjusted for stratification factor and the STAI score at D-7. The application conditions will be checked by studying the residuals. No interim analysis is planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative
Keywords
colon cancer, anxiety, pain, virtual reality, malignant colon tumor, malignant rectum tumor, virtual reality immersion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Determine if virutal reality help reduce postoperative anxiety in patients operated for colorectal cancer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immersive reality group
Arm Type
Experimental
Arm Description
patients receive care according to the usual practices of the department as well as virtual reality. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. Virtual reality headset is put on the day before the operation and in the morning just before going to the operating theatre (only on the morning of the operation for patients hospitalized the same day). The colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number (day and night).
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
patients are treated according to usual practices of the department and do not have access to virtual reality.
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative use of virtual reality headset
Intervention Description
Patient use the virtual reality headset the day before and / or the day of the surgery
Intervention Type
Procedure
Intervention Name(s)
Standard surgery
Intervention Description
Patient are operated as needed for treatment of colorectal cancer (usual care)
Intervention Type
Behavioral
Intervention Name(s)
Post-operative use of virtual reality headset
Intervention Description
Patient use the virtual reality headset as many time as they want after the surgery during a maximum of 30 days
Primary Outcome Measure Information:
Title
Anxiety assessment
Description
Change from State-Trait Anxiety Inventory (STAI-A) scores at D-7 before surgery and at discharge (maximum at day 30 after surgery).
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Total painkiller use (opioids and non-opioids) during hospitalization
Description
painkillers and their use are prescribed and referenced in the software used in our department (Dxcare®). Data will be collected every day to obtain daily and total consumption.
Time Frame
Up to 30 days
Title
Pain assessment
Description
Maximum pain experienced by the patient during the hospital stay using the numerical pain scale (NPS): nurses record patients' pain at least 4 times a day and note it directly in Dxcare® software (NPS 0 = no pain, NPS 10 = maximal pain) .
Time Frame
Up to 30 days
Title
Total anxiolytic use (benzodiazepines, related hypnotics, hydroxyzine) during hospitalization
Description
Anxiolytics and their use are prescribed and referenced in the software used in our department (Dxcare®). Data will be collected every day to obtain daily and total consumption.
Time Frame
Up to 30 days
Title
Adverse effects of virtual reality immersion
Description
Main adverse effects expected (nausea, vomiting, vertigo, headaches). Virtual reality sessions will be subject to a medical prescription on the software used in our department (Dxcare®). To validate each session, nurses will have to answer a questionnaire stating session duration, anxiety level before the session, reasons for a potential refusal, tolerance, possible comments on the programs used and number of sessions per day.
Time Frame
Up to 30 days
Title
Morbidity and mortality
Description
Severe morbidity (Clavien Dindo classification)
Time Frame
Up to 30 days
Title
Confounding factors of anxiety
Description
Measures of depression (CES-D, Center for Epidemiologic Studies - Depression - French version) and alcohol and tobacco consumption are included. These are indeed confounding factors of anxiety and potential moderating factors of virtual reality's effectiveness.
Time Frame
7 days before surgery
Title
Morbidity
Description
Transit recovery time
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with colorectal cancer (colon or rectum), regardless of oncological stage and neo-adjuvant treatments received, or a colorectal lesion judged as endoscopically unresectable, with indication for surgical management either by laparotomy or laparoscopy Elective surgery Patient ≥ 18 years old Patient affiliated to a social security system or entitled to it Patient who has received full information on the research organization and has given written consent Exclusion Criteria: Complicated tumour (perforation, occlusion) requiring emergency surgery Non-French speaking patient Patient subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Pregnant or breastfeeding woman Patient benefiting from the AME Epilepsy Severe visual or hearing impairment that does not allow the use of headphones Autism spectrum disorder Claustrophobia Confusion Medical history of schizophrenia, schizotypal disorders and delusional disorders, and/or patients requiring treatment with : Neuroleptics (Abilify = Aripiprazole and Abilify Now, Clopixol = Zuclopenthixol, Haldol = Haloperidol and Haldol Decanoas, Largactil = Chlorpromazine, Leponex = Clozapine, Loxapac = Loxapine, Nozinan = Levomepromazine, Risperdal = Risperidone and Xeplion and Trevicta, Solian = Amisulpride, Tercian = Cyamemazine, Tiapridal = Tiapride, Xeroquel = Quetiapine, Zyprexa = Olanzapine and Zypadhera); Thymoregulators (Depakote / Depamide = Valproate de Sodium, Lamictal = Lamotrigine, Tegretol = Carbamazepine, Teralithe = Lithium)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick VACHER
Phone
33 1 44 84 17 30
Email
gestion-locale.drc@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha Nohilé
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MANCEAU, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital européen Georges-Pompidou AP-HP
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles MANCEAU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Antoine Cazelles

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD Sharing Time Frame
Two years after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Citations:
PubMed Identifier
29624635
Citation
Mols F, Schoormans D, de Hingh I, Oerlemans S, Husson O. Symptoms of anxiety and depression among colorectal cancer survivors from the population-based, longitudinal PROFILES Registry: Prevalence, predictors, and impact on quality of life. Cancer. 2018 Jun 15;124(12):2621-2628. doi: 10.1002/cncr.31369. Epub 2018 Apr 6.
Results Reference
background
PubMed Identifier
31136330
Citation
Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
Results Reference
background
PubMed Identifier
34637527
Citation
Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
Results Reference
background
PubMed Identifier
29095417
Citation
Parker S, Zipursky J, Ma H, Baumblatt GL, Siegel CA. A Web-based Multimedia Program Before Colonoscopy Increased Knowledge and Decreased Anxiety, Sedation Requirement, and Procedure Time. J Clin Gastroenterol. 2018 Jul;52(6):519-523. doi: 10.1097/MCG.0000000000000958.
Results Reference
background

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Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer

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