Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure (VRH-PAC)

University of Liege

Status: Not yet enrolling

Conditions: Cancer

Treatments: Device: Virtual reality hypnosis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06883786

VRH-PAC

Details and patient eligibility

About

The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Low auditory and/or visual acuity precludes the use of the device.
• Head or face wounds precluding the use of the device.
• Schizophrenia, dissociative disorder or any other psychiatric disorder.
• Non-proficiency in French (Research language).
• Patient under 18 years old.
• Phobia of deep water.
• Dizziness.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Virtual reality hypnosis

Experimental group

Description:

The VRH session, called Aqua+© (120 Version 1.1, HypnoVR SAS, Strasbourg, France) It is an immersive and contemplative virtual experience combining music, sounds, and/or a vocal audio recording relating a hypnotic scenario and a 3D virtual video. The Aqua© VRH session follows the standard phases of hypnosis, beginning with induction, followed by suggestions, and ending with the exit of hypnosis.

Treatment:

Device: Virtual reality hypnosis

Control

No Intervention group

Description:

Usual care. Local anesthesia only.