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

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Virtual reality hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRH<br>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). | Device: Virtual reality hypnosis<br>* 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.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Assessed with a numerical rating scale (0= no anxiety; 10= worst 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety trait | 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 | One week before the Radiofrquency | 
| Pain intensity | Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable). | One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency | 
| Immersive tendencies | 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. | On the day of the radiofrequency before the VRH/Ctr | 
| Sens of presence | 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. | Right after the VRH/Ctr | 
| Satisfaction | Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction). | After the radiofrequency, Average 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality hypnosis, Radiofrequency thermocoagulation, Chronic pain, Anxiety, Complementary approach