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

Rennes University Hospital

Status: Completed

Conditions: Anaesthesia

Treatments: Other: negative connotation communication; Other: peripheral intravenous catheterization; Other: neutral connotation communication; Other: Hypnotic communication

Study type: Interventional

Funder types: Other

Identifiers

NCT02662322

35RC15_9868

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 3 patient groups, including a placebo group

HYPNOSIS

Experimental group

Description:

hypnotic communication, confusion procedure during peripheral intravenous catheterization

Treatment:

Other: peripheral intravenous catheterization

Other: Hypnotic communication

NOCEBO

Active Comparator group

Description:

negative connotation communication during peripheral intravenous catheterization

Treatment:

Other: peripheral intravenous catheterization

Other: negative connotation communication

NEUTRAL

Placebo Comparator group

Description:

neutral connotation communication during peripheral intravenous catheterization

Treatment:

Other: peripheral intravenous catheterization

Other: neutral connotation communication