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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual reality hypnosis
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Virtual reality hypnosis, Radiofrequency thermocoagulation, Chronic pain, Anxiety, Complementary approach

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VRH

Control

Arm Description

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).

Usual care

Outcomes

Primary Outcome Measures

Anxiety
Assessed with a numerical rating scale (0= no anxiety; 10= worst anxiety).

Secondary Outcome Measures

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
Pain intensity
Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable).
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.
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.
Satisfaction
Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction).

Full Information

First Posted
September 12, 2023
Last Updated
October 12, 2023
Sponsor
University of Liege
Collaborators
Centre Hospitalier Universitaire de Liege
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1. Study Identification

Unique Protocol Identification Number
NCT06082427
Brief Title
Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain
Official Title
Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Centre Hospitalier Universitaire de Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Virtual reality hypnosis, Radiofrequency thermocoagulation, Chronic pain, Anxiety, Complementary approach

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VRH
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
Virtual reality hypnosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
Assessed with a numerical rating scale (0= no anxiety; 10= worst anxiety).
Time Frame
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 Measure Information:
Title
Anxiety trait
Description
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
Time Frame
One week before the Radiofrquency
Title
Pain intensity
Description
Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable).
Time Frame
One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency
Title
Immersive tendencies
Description
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.
Time Frame
On the day of the radiofrequency before the VRH/Ctr
Title
Sens of presence
Description
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.
Time Frame
Right after the VRH/Ctr
Title
Satisfaction
Description
Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction).
Time Frame
After the radiofrequency, Average 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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