Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Device: Virtual reality hypnosis
- Registration Number
- NCT06082427
- Lead Sponsor
- University of Liege
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VRH Virtual reality hypnosis 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).
- Primary Outcome Measures
Name Time Method Anxiety One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency Assessed with a numerical rating scale (0= no anxiety; 10= worst anxiety).
- Secondary Outcome Measures
Name Time Method Anxiety trait One week before the Radiofrquency Assessed with the State-Trait Anxiety Inventory. This questionnaire includes 20 items assessing trait anxiety The scores can vary from 20 to 80. The higher the score, the more the individual is said to be anxious
Satisfaction After the radiofrequency, Average 1 hour Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction).
Sens of presence Right after the VRH/Ctr The 12-item Presence Questionnaire is a self-made questionnait that assesses patients' feelings during the experience in the immersive environment. All items are rated from 1 to 7 The higher the scores, the more impressions experienced by the participants are perceived as real.
Immersive tendencies On the day of the radiofrequency before the VRH/Ctr Immersive tendencies questionnaire contains 18 items rated on a scale of 1 (never) to 7 (often). It contains 4 sub-scales : "Focus" is the tendency to stay focused on ongoing activities; "Involvement" is the tendency to become involved in activities ; "Emotion" is the tendency to be emotionally involved by the environment; "Game" is the tendency to play video games. A total score is also available, and it varies from 18 to 126. The higher the score, the higher the tendency for immersion in the virtual environment.
Pain intensity One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable).
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium