NCT06082427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 12, 2023

Last Update Submit

October 12, 2023

Conditions

Chronic Pain

Keywords

Virtual reality hypnosisRadiofrequency thermocoagulationChronic painAnxietyComplementary approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Anxiety trait

    One week before the Radiofrquency

  • 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

  • Immersive tendencies

    On the day of the radiofrequency before the VRH/Ctr

  • Sens of presence

    Right after the VRH/Ctr

  • Satisfaction

    After the radiofrequency, Average 1 hour

Study Arms (2)

VRH

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care

Interventions

Virtual reality hypnosisDEVICE

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.

VRH

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Chronic PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 13, 2023

Study Start

March 1, 2021

Primary Completion

July 30, 2022

Study Completion

March 31, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)