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The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).
Clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (PIVC). However, suggestions for negative perceptual experiences causes more pain and anxiety. During This does not improve at all the real-life experience of the act. On the contrary, the use of gentler words improves pain perception and subjective patient experience. Furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYPNOSIS | Experimental | hypnotic communication, confusion procedure during peripheral intravenous catheterization |
|
| NOCEBO | Active Comparator | negative connotation communication during peripheral intravenous catheterization |
|
| NEUTRAL | Placebo Comparator | neutral connotation communication during peripheral intravenous catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnotic communication | Other | hypnotic communication during peripheral intravenous catheterization |
|
| Measure | Description | Time Frame |
|---|---|---|
| numerical rating scale for pain from 0 to 10 | self-evaluation of pain catheterization | data collected within 3 min after the end of peripheral intravenous catheterization procedure |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of numerical rating scale for comfort from 0 to 10 | self-evaluation of comfort catheterization | data collected just before and within 3 min after peripheral intravenous catheterization procedure |
| evolution of numerical rating scale for anxiety from 0 to 10 |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Helene Beloeil, PH | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | 10 1200 | Belgium | |||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31862159 | Derived | Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18. |
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| negative connotation communication | Other | negative connotation communication during peripheral intravenous catheterization |
|
| neutral connotation communication | Other | neutral connotation communication during peripheral intravenous catheterization |
|
| peripheral intravenous catheterization | Other | peripheral intravenous catheterization |
|
self-evaluation of anxiety catheterization |
| data collected just before and within 3 min after peripheral intravenous catheterization procedure |
| presence of spontaneous patient arm withdrawal | data collected within 3 min after the end of peripheral intravenous catheterization procedure |
| presence of unprompted vocalization by word(s) or sound(s) | data collected within 3 min after the end of peripheral intravenous catheterization procedure |
| Rennes |
| 35033 |
| France |
| Centre Hospitalier Privé Saint Grégoire | Saint-Grégoire | 35768 | France |
| ID | Term |
|---|---|
| D003142 | Communication |
| D003221 | Confusion |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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