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

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

Interventions

BEHAVIORAL

Pre-operative use of virtual reality headset

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

PROCEDURE

Standard surgery

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

BEHAVIORAL

Post-operative use of virtual reality headset

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

Sponsors & Collaborators

• VR 4 GOOD

  collaborator UNKNOWN

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Gilles MANCEAU, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-31

Primary Completion

2024-07-31

Completion

2024-07-31

Countries

• France

Study Locations