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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2017-09-06

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).

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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.

Conditions

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Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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HYPNOSIS

hypnotic communication, confusion procedure during peripheral intravenous catheterization

Group Type EXPERIMENTAL

Hypnotic communication

Intervention Type OTHER

hypnotic communication during peripheral intravenous catheterization

peripheral intravenous catheterization

Intervention Type OTHER

peripheral intravenous catheterization

NOCEBO

negative connotation communication during peripheral intravenous catheterization

Group Type ACTIVE_COMPARATOR

negative connotation communication

Intervention Type OTHER

negative connotation communication during peripheral intravenous catheterization

peripheral intravenous catheterization

Intervention Type OTHER

peripheral intravenous catheterization

NEUTRAL

neutral connotation communication during peripheral intravenous catheterization

Group Type PLACEBO_COMPARATOR

neutral connotation communication

Intervention Type OTHER

neutral connotation communication during peripheral intravenous catheterization

peripheral intravenous catheterization

Intervention Type OTHER

peripheral intravenous catheterization

Interventions

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Hypnotic communication

hypnotic communication during peripheral intravenous catheterization

Intervention Type OTHER

negative connotation communication

negative connotation communication during peripheral intravenous catheterization

Intervention Type OTHER

neutral connotation communication

neutral connotation communication during peripheral intravenous catheterization

Intervention Type OTHER

peripheral intravenous catheterization

Intervention Type OTHER

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

* patient unable to communicate in french
* difficult vein access characteristics
* premedication
* pregnant, breast-feeding woman
* patient subject of legal protection