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

• Sponsor: University of Liege (Other)
• Overall Status: Completed
• CT.gov ID: NCT06082427
• Collaborator: Centre Hospitalier Universitaire de Liege (Other)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Virtual reality hypnosis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Jul 30, 2022
• Actual Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VRH 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; 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.
No Intervention: Control Usual care

Outcome Measures

Primary Outcome Measures

1. 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]

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

Secondary Outcome Measures

1. Anxiety trait [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 [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 [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 [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 [After the radiofrequency, Average 1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Liège	Liège		Belgium	4000

Sponsors and Collaborators

• University of Liege
• Centre Hospitalier Universitaire de Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Audrey Vanhaudenhuyse, Principal Investigator, University of Liege
• ClinicalTrials.gov Identifier: NCT06082427
• Other Study ID Numbers: /344
• First Posted: Oct 13, 2023
• Last Update Posted: Oct 13, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Audrey Vanhaudenhuyse, Principal Investigator, University of Liege: Virtual reality hypnosis; Radiofrequency thermocoagulation; Chronic pain; Anxiety; Complementary approach
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Oct 13, 2023