PainPADISNCT04869553
Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care
A study testing Management pain with distraction methods ABC, Management pain with distraction methods BCA and Management pain with distraction methods CAB in people with Pain, run by Lille Catholic University at 5 sites in France.
Trial summary
The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Management pain with distraction methods ABC, Management pain with distraction methods BCA and Management pain with distraction methods CAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Jan 2022to 24 May 2024
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing care interventions of a given type (e.g. wound dressings/mobilization/…) recognized as painful (pain VAS >3 despite the usual analgesic protocol)
- Repetition of the same type of intervention at least three times within a month of interval after inclusion
- Patient age ≥15 years
- Informed consent from patient or legal guardian
- Beneficiary of the French healthcare fund
Who cannot join
- MEOPA's administration during painful treatment as part of the study
- Cognitive or psychiatric disorders preventing the patient from communicating with caregivers or understanding their instructions
- Any other concomitant nervous system, cardiac, or pulmonary disease that might affect the autonomous nervous system: (myocardial infarction, myocardial disorder (e.g. dilated or hypertrophic cardiomyopathy), class 3 or 4 heart failure, cardia dysrhythmia, including atrial fibrillation, conduction disorder, mechanical ventilation)
- Non-sinusal rhythm, extrasystoles, altered ECG signals related to heart disease
- Mandatory drug therapy that might affect the autonomous nervous system and NRV such as beta-blockers, muscarinic receptor blockers (mainly atropine, scopolamine), vasopressin agents
- Contraindication for use of the virtual reality headset and/or hypnosis. Neurological disorder incompatible with use of the virtual reality headset and/or hypnosis (balance disorders/seizures…)
Show all 9Show fewer
- Contraindication for using surface electrodes preventing collection of the main endpoint data
- Any disorder or disability preventing execution of the virtual reality or hypnosis techniques (deafness/blindness)
- Judicial protection status
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Léon Bérard
Hyères, 83418
USSAP - Centre Bouffard Vercelli
Perpignan, 66962
Centre Mutualiste de Kerpape
Ploemeur, 56275
Pôle MPR Saint Hélier
Rennes, 35043
Fondation ILDYS - Site de Perharidy
Roscoff, 29684
About this study
Official title: Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study
The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
Read the detailed description
Pain is defined as an unpleasant sensorial and emotional experience related to a potential or existing tissue injury (psychological (affective) and physical dimension of pain). Since it can occur at any stage of care, pain concerns all healthcare teams working in acute care units or follow-up care centers.
At the present time, pain management is mainly based on the use of analgesic agents that calm or suppress pain. Different types of analgesic agents are available in the therapeutic armamentarium (non-opioid analgesics and opioid analgesics as morphine).
In this context where pain management is a priority and where the use of morphine is constantly on the rise exposing patients to significant risk (adverse effects, addictions, respiratory events….), the use of distractibility techniques as hypnosis and virtual reality could be an attractive alternative.
- Hypnosis designates both a therapeutic technique and a modified state of consciousness also called trance (a state where the person is between a state of wakefulness and sleep).
- Virtual reality designates a three-dimensional computer-controlled environment allowing immersion, interaction and multisensorial input.
Thus, the originality of this study is the comparison of different distractibility techniques in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
- Conditions
- Pain
- Being tested
- Management pain with distraction methods ABC, Management pain with distraction methods BCA, Management pain with distraction methods CAB
- Keywords
- Pain management, Hypnosis, Virtual Reality, Distractibility methods
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management pain with distraction methods ABCOther
Every patient will receive :
- The usual pain management of their ward (Treatment A),
- The usual pain management of their ward with a hypnosis session (Treatment B)
- The usual pain management of their ward with a virtual reality session (Treatment C)
Management pain with distraction methods BCAOther
Every patient will receive :
- The usual pain management of their ward with a hypnosis session (Treatment B)
- The usual pain management of their ward with a virtual reality session (Treatment C)
- The usual pain management of their ward (Treatment A)
Management pain with distraction methods CABOther
Every patient will receive :
- The usual pain management of their ward with a virtual reality session (Treatment C)
- The usual pain management of their ward (Treatment A)
- The usual pain management of their ward with a hypnosis session (Treatment B)
| Study group | Role | What they receive |
|---|---|---|
| ABC's arm | Experimental | The 3 pain managements are in the ABC's order. Receives: Other: Management pain with distraction methods ABC |
| BCA's arm | Experimental | The 3 pain managements are in the BCA's order. Receives: Other: Management pain with distraction methods BCA |
| CAB's arm | Experimental | The 3 pain managements are in the CAB's order. Receives: Other: Management pain with distraction methods CAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia Nociception Index (ANI) during painful care interventions
This index is derived from heart rate variability and reflects the relative parasympathetic tone. An ANI value close to 100 corresponds to a prominent parasympathetic tone (low stress level, analgesia) and a value close to 0 corresponds to a prominent sympathetic tone (high stress level, nociception).
Measured: one month
Secondary outcomes (9)
ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods
A comparison between the ANI's score before and after the care and the distractibility methods. The average of the scores will be retained.
Measured: one month
Visual Analog Scale (VAS)
The pain's level will be evaluated by the Visual Analog Scale (VAS). This scale measure the pain's intensity from 0 to 10.
Measured: one month
Morphine equivalent
The opioid analgesics administered during the care will be converted into morphine equivalent by means of the opioid equi-analgesia table. The collection of analgesics will include all analgesics "in action" on the day of care.
Measured: one month
Proportion of patients tolerance to distractibility techniques
All events leading to a discontinuation of the distractibility technique will be recorded: side effects /cybersickness (nausea, vertigo evaluated using the Speech, Spatial and Qualities (SSQ) of Hearing Scale prolonged procedure, dissociative disorders …), patient refusal, care-related elements preventing the use of the distractibility technique or leading to premature discontinuation of its use.
Measured: one month
Correlation between patient age and tolerance
The impact of age on abandon (irrespective of the reason) will be noted to search for a link between age and tolerance.
Measured: one month
Correlation between patient age and treatment efficacy
The impact of age on treatment effect on ANI score during the care procedure will be noted to search for a link between age and treatment efficacy.
Measured: one months
Correlation between caregiver training level and hypnosis efficacy
Hypnosis training level will be determined by the duration of training (hours) and the professional level (1/2/3). Caregiver category (nurse/psychologist/rehabilitation specialist…) and the number of hypno-therapy sessions delivered during the six months preceding the study will also be considered.
Measured: one month
Percentage of satisfaction concerning the distractibility techniques.
A questionnaire will evaluate patient perceptions concerning the distractibility techniques.
Measured: one month
IPQ (Igroup Presence Questionnaire) scale
The IPQ is a 14-item self-administered questionnaire. This scale is used to measure the patient's feelings about spatial presence, the implication and sense of the reality perceived in the virtual reality.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start7 Jan 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Model description
- Controlled, randomised, open-label, cross-over, 3-sequence study (uniform design across time and sequence: ABC/BCA/CAB). * Treatment A: Usual pain management of each ward * Treatment B: Usual pain management on each ward and analgesic hypnotherapy during care * Treatment C: Usual pain management of each ward and virtual reality session using a suitable headset.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Noëlle BARTHOLOMEI, PharmD, Study director, Hôpital Léon Bérard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869553
- Sponsor's protocol ID
- RC-P00102
- Acronym
- PADIS
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2021
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study
- ClinicalTrials.gov ID
- NCT04869553
- Acronym / sponsor ID
- PADIS / RC-P00102
- Conditions
- Pain
- Keywords
- Pain management, Hypnosis, Virtual Reality, Distractibility methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 3 May 2021 (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.
The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
Detailed description
Pain is defined as an unpleasant sensorial and emotional experience related to a potential or existing tissue injury (psychological (affective) and physical dimension of pain). Since it can occur at any stage of care, pain concerns all healthcare teams working in acute care units or follow-up care centers.
At the present time, pain management is mainly based on the use of analgesic agents that calm or suppress pain. Different types of analgesic agents are available in the therapeutic armamentarium (non-opioid analgesics and opioid analgesics as morphine).
In this context where pain management is a priority and where the use of morphine is constantly on the rise exposing patients to significant risk (adverse effects, addictions, respiratory events….), the use of distractibility techniques as hypnosis and virtual reality could be an attractive alternative.
- Hypnosis designates both a therapeutic technique and a modified state of consciousness also called trance (a state where the person is between a state of wakefulness and sleep).
- Virtual reality designates a three-dimensional computer-controlled environment allowing immersion, interaction and multisensorial input.
Thus, the originality of this study is the comparison of different distractibility techniques in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Controlled, randomised, open-label, cross-over, 3-sequence study (uniform design across time and sequence: ABC/BCA/CAB). * Treatment A: Usual pain management of each ward * Treatment B: Usual pain management on each ward and analgesic hypnotherapy during care * Treatment C: Usual pain management of each ward and virtual reality session using a suitable headset.
| Arm | Type | Receives |
|---|---|---|
| ABC's arm | Experimental | Other: Management pain with distraction methods ABCThe 3 pain managements are in the ABC's order. |
| BCA's arm | Experimental | Other: Management pain with distraction methods BCAThe 3 pain managements are in the BCA's order. |
| CAB's arm | Experimental | Other: Management pain with distraction methods CABThe 3 pain managements are in the CAB's order. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing care interventions of a given type (e.g. wound dressings/mobilization/…) recognized as painful (pain VAS >3 despite the usual analgesic protocol)
- Repetition of the same type of intervention at least three times within a month of interval after inclusion
- Patient age ≥15 years
- Informed consent from patient or legal guardian
- Beneficiary of the French healthcare fund
Key exclusion criteria (9 listed)
- MEOPA's administration during painful treatment as part of the study
- Cognitive or psychiatric disorders preventing the patient from communicating with caregivers or understanding their instructions
- Any other concomitant nervous system, cardiac, or pulmonary disease that might affect the autonomous nervous system: (myocardial infarction, myocardial disorder (e.g. dilated or hypertrophic cardiomyopathy), class 3 or 4 heart failure, cardia dysrhythmia, including atrial fibrillation, conduction disorder, mechanical ventilation)
- Non-sinusal rhythm, extrasystoles, altered ECG signals related to heart disease
- Mandatory drug therapy that might affect the autonomous nervous system and NRV such as beta-blockers, muscarinic receptor blockers (mainly atropine, scopolamine), vasopressin agents
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 |
|---|---|---|
| Management pain with distraction methods ABCEvery patient will receive : * The usual pain management of their ward (Treatment A), * The usual pain management of their ward with a hypnosis session (Treatment B) * The usual pain management of their ward with a virtual reality session (Treatment C) | Other | ABC's arm |
| Management pain with distraction methods BCAEvery patient will receive : * The usual pain management of their ward with a hypnosis session (Treatment B) * The usual pain management of their ward with a virtual reality session (Treatment C) * The usual pain management of their ward (Treatment A) | Other | BCA's arm |
| Management pain with distraction methods CABEvery patient will receive : * The usual pain management of their ward with a virtual reality session (Treatment C) * The usual pain management of their ward (Treatment A) * The usual pain management of their ward with a hypnosis session (Treatment B) | Other | CAB's arm |
Primary outcome
Analgesia Nociception Index (ANI) during painful care interventions
Time frame: one month
This index is derived from heart rate variability and reflects the relative parasympathetic tone. An ANI value close to 100 corresponds to a prominent parasympathetic tone (low stress level, analgesia) and a value close to 0 corresponds to a prominent sympathetic tone (high stress level, nociception).
9 secondary outcomes
ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods
Time frame: one month
Visual Analog Scale (VAS)
Time frame: one month
Morphine equivalent
Time frame: one month
Proportion of patients tolerance to distractibility techniques
Time frame: one month
Correlation between patient age and tolerance
Time frame: one month
Correlation between patient age and treatment efficacy
Time frame: one months
Correlation between caregiver training level and hypnosis efficacy
Time frame: one month
Percentage of satisfaction concerning the distractibility techniques.
Time frame: one month
IPQ (Igroup Presence Questionnaire) scale
Time frame: one month
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 10 Sep 2025.
- 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.
Marie-Noëlle BARTHOLOMEI, PharmD study director
Hôpital Léon Bérard
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management pain with distraction methods ABC, Management pain with distraction methods BCA and Management pain with distraction methods CAB in people with Pain, run by Lille Catholic University at 5 sites in France.
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 5 inclusion and 9 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Analgesia Nociception Index (ANI) during painful care interventions (time frame: one month). 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 10 Sep 2025.