Chronic PainNCT06082427
Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain
A study testing Virtual reality hypnosis in people with Chronic Pain, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Virtual reality hypnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial
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.
- Conditions
- Chronic Pain
- Being tested
- Virtual reality hypnosis
- Keywords
- Virtual reality hypnosis, Radiofrequency thermocoagulation, Chronic pain, Anxiety, Complementary approach
- Medical subject headings
- Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Virtual reality hypnosis |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Assessed with a numerical rating scale (0= no anxiety; 10= worst anxiety).
Measured: 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
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
Measured: One week before the Radiofrquency
Pain intensity
Assessed with a numerical rating scale (0= no pain; 10= worst pain immaginable).
Measured: 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
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.
Measured: On the day of the radiofrequency before the VRH/Ctr
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.
Measured: Right after the VRH/Ctr
Satisfaction
Assessed with a numerical rating scale (0= total dissatisfaction, 10= total satisfaction).
Measured: After the radiofrequency, Average 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Mar 2021
- Primary completion30 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082427
- Sponsor's protocol ID
- /344
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06082427
- Acronym / sponsor ID
- /344
- Conditions
- Chronic Pain
- Keywords
- Virtual reality hypnosis, Radiofrequency thermocoagulation, Chronic pain, Anxiety, Complementary approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRH | Experimental | Device: Virtual reality hypnosisVRH 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). |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- suffering from chronic pain
- >18 years old
- French speaking
- no claustrophobia
- no head or face wounds
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality hypnosisVRH 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. | Device | VRH |
Primary outcome
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).
5 secondary outcomes
Anxiety trait
Time frame: One week before the Radiofrquency
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
Immersive tendencies
Time frame: On the day of the radiofrequency before the VRH/Ctr
Sens of presence
Time frame: Right after the VRH/Ctr
Satisfaction
Time frame: After the radiofrequency, Average 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality hypnosis in people with Chronic Pain, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.