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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06082427
Other study ID # /344
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 31, 2023

Study information

Verified date October 2023
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date March 31, 2023
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Belgium Centre Hospitalier Universitaire de Liège Liège

Sponsors (2)

Lead Sponsor Collaborator
University of Liege Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Satisfaction Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction). After the radiofrequency, Average 1 hour
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