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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC's arm | Experimental | The 3 pain managements are in the ABC's order. |
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| BCA's arm | Experimental | The 3 pain managements are in the BCA's order. |
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| CAB's arm | Experimental | The 3 pain managements are in the CAB's order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Management pain with distraction methods ABC | Other | Every patient will receive :
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | one month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month |
| Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Noëlle BARTHOLOMEI, PharmD | Hôpital Léon Bérard | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Léon Bérard | Hyères | 83418 | France | |||
| USSAP - Centre Bouffard Vercelli |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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Controlled, randomised, open-label, cross-over, 3-sequence study (uniform design across time and sequence: ABC/BCA/CAB).
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| Management pain with distraction methods BCA | Other | Every patient will receive :
|
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| Management pain with distraction methods CAB | Other | Every patient will receive :
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The pain's level will be evaluated by the Visual Analog Scale (VAS). This scale measure the pain's intensity from 0 to 10. |
| 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. | 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. | 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. | 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. | 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. | one month |
| Percentage of satisfaction concerning the distractibility techniques. | A questionnaire will evaluate patient perceptions concerning the distractibility techniques. | 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. | one month |
| Perpignan |
| 66962 |
| France |
| Centre Mutualiste de Kerpape | Ploemeur | 56275 | France |
| Pôle MPR Saint Hélier | Rennes | 35043 | France |
| Fondation ILDYS - Site de Perharidy | Roscoff | 29684 | France |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |