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

NCT05653934 | Unknown

• 2 other identifiers: APHP211134IDRCB 2021-A01436-35
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Tumor, Malignant; Rectum Tumor; Pain, Postoperative

Keywords

colon cancer; anxiety; pain; virtual reality; malignant colon tumor; malignant rectum tumor; virtual reality immersion

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 30 days

Secondary Outcomes (7)

• Total painkiller use (opioids and non-opioids) during hospitalization

  Up to 30 days

• Pain assessment

  Up to 30 days

• Total anxiolytic use (benzodiazepines, related hypnotics, hydroxyzine) during hospitalization

  Up to 30 days

• Adverse effects of virtual reality immersion

  Up to 30 days

• Morbidity and mortality

  Up to 30 days

Study Arms (2)

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).

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.

Procedure: Standard surgery

Interventions

Pre-operative use of virtual reality headset BEHAVIORAL

Patient use the virtual reality headset the day before and / or the day of the surgery

Immersive reality group

Standard surgery PROCEDURE

Patient are operated as needed for treatment of colorectal cancer (usual care)

Immersive reality group; Standard care group

Post-operative use of virtual reality headset BEHAVIORAL

Patient use the virtual reality headset as many time as they want after the surgery during a maximum of 30 days

Immersive reality group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• VR 4 GOOD: collaborator

Study Sites (1)

Hôpital européen Georges-Pompidou AP-HP

Paris, 75015, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 29624635 BACKGROUND

• 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.

  PMID: 31136330 BACKGROUND

• 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.

  PMID: 34637527 BACKGROUND

• 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.

  PMID: 29095417 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Pain, Postoperative; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Gilles MANCEAU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick VACHER

CONTACT

33 1 44 84 17 30; gestion-locale.drc@aphp.fr

Natacha Nohilé

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Determine if virutal reality help reduce postoperative anxiety in patients operated for colorectal cancer

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: December 16, 2022
• Study Start: May 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• 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).

Locations

FR (1)