Colon Tumor, MalignantVIREANCT05653934
Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer
A study testing Pre-operative use of virtual reality headset, Standard surgery and Post-operative use of virtual reality headset in people with Colon Tumor, Malignant and Rectum Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative
- What is being tested?
- Pre-operative use of virtual reality headset, Standard surgery and Post-operative use of virtual reality headset
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- May 2023to Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Natacha Nohilé contact
France1 site, 1 recruiting
- Recruiting
Hôpital européen Georges-Pompidou AP-HP
Paris, 75015
Gilles MANCEAU, MD, PhD
Antoine Cazelles
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative
- Being tested
- Pre-operative use of virtual reality headset, Standard surgery, Post-operative use of virtual reality headset
- Keywords
- colon cancer, anxiety, pain, virtual reality, malignant colon tumor, malignant rectum tumor, virtual reality immersion
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative use of virtual reality headsetBehavioural
Patient use the virtual reality headset the day before and / or the day of the surgery
Standard surgeryProcedure or surgery
Patient are operated as needed for treatment of colorectal cancer (usual care)
Post-operative use of virtual reality headsetBehavioural
Patient use the virtual reality headset as many time as they want after the surgery during a maximum of 30 days
| Study group | Role | What they receive |
|---|---|---|
| Immersive reality group | Experimental | 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). Receives: Behavioral: Pre-operative use of virtual reality headset; Procedure: Standard surgery; Behavioral: Post-operative use of virtual reality headset |
| Standard care group | Active comparator | patients are treated according to usual practices of the department and do not have access to virtual reality. Receives: Procedure: Standard surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 30 days
Secondary outcomes (7)
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.
Measured: Up to 30 days
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) .
Measured: Up to 30 days
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.
Measured: Up to 30 days
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.
Measured: Up to 30 days
Morbidity and mortality
Severe morbidity (Clavien Dindo classification)
Measured: Up to 30 days
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.
Measured: 7 days before surgery
Morbidity
Transit recovery time
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study startMay 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon Tumor, MalignantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Determine if virutal reality help reduce postoperative anxiety in patients operated for colorectal cancer
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- VR 4 GOOD
- Responsible party
- Sponsor
- Investigators
- Gilles MANCEAU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653934
- Sponsor's protocol ID
- APHP211134
- Other IDs
- IDRCB 2021-A01436-35
- Acronym
- VIREA
- Status last verified
- Apr 2023
- First submitted
- 3 Oct 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
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.
PubMed 29624635Eijlers 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.
PubMed 31136330Bradt 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.
PubMed 34637527Parker 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.
PubMed 29095417
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05653934
- Acronym / sponsor ID
- VIREA / APHP211134
- Conditions
- Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative
- Keywords
- colon cancer, anxiety, pain, virtual reality, malignant colon tumor, malignant rectum tumor, virtual reality immersion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- VR 4 GOOD
- Study start
- May 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 Dec 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Determine if virutal reality help reduce postoperative anxiety in patients operated for colorectal cancer
| Arm | Type | Receives |
|---|---|---|
| Immersive reality group | Experimental | Behavioral: Pre-operative use of virtual reality headset, Procedure: Standard surgery, Behavioral: Post-operative use of virtual reality headsetpatients 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). |
| Standard care group | Active comparator | Procedure: Standard surgerypatients are treated according to usual practices of the department and do not have access to virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Pre-operative use of virtual reality headsetPatient use the virtual reality headset the day before and / or the day of the surgery | Behavioural | Immersive reality group |
| Standard surgeryPatient are operated as needed for treatment of colorectal cancer (usual care) | Procedure or surgery | Immersive reality group, Standard care group |
| Post-operative use of virtual reality headsetPatient use the virtual reality headset as many time as they want after the surgery during a maximum of 30 days | Behavioural | Immersive reality group |
Primary outcome
Anxiety assessment
Time frame: Up to 30 days
Change from State-Trait Anxiety Inventory (STAI-A) scores at D-7 before surgery and at discharge (maximum at day 30 after surgery).
7 secondary outcomes
Total painkiller use (opioids and non-opioids) during hospitalization
Time frame: Up to 30 days
Pain assessment
Time frame: Up to 30 days
Total anxiolytic use (benzodiazepines, related hypnotics, hydroxyzine) during hospitalization
Time frame: Up to 30 days
Adverse effects of virtual reality immersion
Time frame: Up to 30 days
Morbidity and mortality
Time frame: Up to 30 days
Confounding factors of anxiety
Time frame: 7 days before surgery
Morbidity
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 29624635Mols 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.
- Background: PubMed 31136330Eijlers 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.
- Background: PubMed 34637527Bradt 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.
- Background: PubMed 29095417Parker 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Natacha Nohilé contact
Gilles MANCEAU, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative use of virtual reality headset, Standard surgery and Post-operative use of virtual reality headset in people with Colon Tumor, Malignant and Rectum Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick VACHER (33 1 44 84 17 30, gestion-locale.drc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety assessment (time frame: Up to 30 days). 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 NCT05653934, which also lists 4 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 19 Apr 2023.