Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain

NCT ID: NCT06082427

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-03-31

Brief Summary

Management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VRH

VRH was delivered through a 3D virtual reality headpiece equipped with a head-tracking system called " IPNEO " and designed by the society Cayceo (Montpellier, France, https://cayceo.fr/). The device display an enchanted environment movie based on hypnosis induction and suggestions (relaxation, comfort, and safety).

Group Type: EXPERIMENTAL

Virtual reality hypnosis

Intervention Type: DEVICE

VRH was delivered through a 3D virtual reality headpiece equipped with a head-tracking system based on hypnosis induction and suggestions (relaxation, comfort, and safety). The complete intervention lasted 17 minutes.

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality hypnosis

VRH was delivered through a 3D virtual reality headpiece equipped with a head-tracking system based on hypnosis induction and suggestions (relaxation, comfort, and safety). The complete intervention lasted 17 minutes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• suffering from chronic pain
• >18 years old
• French speaking
• no claustrophobia
• no head or face wounds
• sufficient auditory and visual acuity for an effective use of the VRH technique

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Audrey Vanhaudenhuyse

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Countries

Belgium

Other Identifiers

/344

Identifier Type: -

Identifier Source: org_study_id