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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06082427
• Other study ID #: /344
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain

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