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Completed

NCT Number: NCT06082427

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

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.

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Key information

Conditions

Chronic Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Hypnosis

Device

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 outcomes

  1. 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

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

Secondary outcomes

  1. Anxiety trait

    Time frame: One week before the Radiofrquency

    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

  2. Pain intensity

    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

    Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable).

  3. Immersive tendencies

    Time frame: On the day of the radiofrequency before the VRH/Ctr

    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.

  4. Sens of presence

    Time frame: Right after the VRH/Ctr

    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.

  5. Satisfaction

    Time frame: After the radiofrequency, Average 1 hour

    Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Centre Hospitalier Universitaire de Liege

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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