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Not Yet Recruiting NCT05653934

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

Conditions: Colon Tumor, Malignant, Rectum Tumor, Pain, Postoperative

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 124
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: France

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.

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 laparoscopyElective surgeryPatient ≥ 18 years oldPatient affiliated to a social security system or entitled to itPatient who has received full information on the research organization and has given written consentExclusion Criteria:Complicated tumour (perforation, occlusion) requiring emergency surgeryNon-French speaking patientPatient subject to a legal protection measure (guardianship, curatorship, safeguard of justice)Pregnant or breastfeeding womanPatient benefiting from the AMEEpilepsySevere visual or hearing impairment that does not allow the use of headphonesAutism spectrum disorderClaustrophobiaConfusionMedical 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)

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Source: ClinicalTrials.gov (NCT05653934). StuddyBuddy aggregates publicly available trial information.