Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Language and Confusion on Pain During Peripheral Intravenous

Conditions
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Anaesthesia

Intervention / Treatment
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* Other: Hypnotic communication
* Other: negative connotation communication
* Other: neutral connotation communication
* Other: peripheral intravenous catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years peripheral intravenous catheterization of 20 G on the dorsal face of the hand before a planned surgery written and informed patient consent Non inclusion Criteria: patient unable to communicate in french difficult vein access characteristics premedication pregnant, breast-feeding woman patient subject of legal protection Exclusion criteria : failed of the first attempt of peripheral intravenous catheterization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYPNOSIS<br>hypnotic communication, confusion procedure during peripheral intravenous catheterization | Other: Hypnotic communication<br>* hypnotic communication during peripheral intravenous catheterization<br>Other: peripheral intravenous catheterization<br>* peripheral intravenous catheterization<br>|
| Active Comparator: NOCEBO<br>negative connotation communication during peripheral intravenous catheterization | Other: negative connotation communication<br>* negative connotation communication during peripheral intravenous catheterization<br>Other: peripheral intravenous catheterization<br>* peripheral intravenous catheterization<br>|
| Placebo Comparator: NEUTRAL<br>neutral connotation communication during peripheral intravenous catheterization | Other: neutral connotation communication<br>* neutral connotation communication during peripheral intravenous catheterization<br>Other: peripheral intravenous catheterization<br>* peripheral intravenous catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Communication, Confusion, Intravenous Catheterization, Comfort