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

Not Applicable

Completed

• Conditions: Anaesthesia

• Registration Number: NCT02662322
• Lead Sponsor: Rennes University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-25
• Study Start: 2016-03-10
• Primary Completion: 2017-03-06
• Study Completion: 2017-09-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
numerical rating scale for pain from 0 to 10	data collected within 3 min after the end of peripheral intravenous catheterization procedure	self-evaluation of pain catheterization

Secondary Outcome Measures

Name	Time	Method
evolution of numerical rating scale for comfort from 0 to 10	data collected just before and within 3 min after peripheral intravenous catheterization procedure	self-evaluation of comfort catheterization
presence of unprompted vocalization by word(s) or sound(s)	data collected within 3 min after the end of peripheral intravenous catheterization procedure
presence of spontaneous patient arm withdrawal	data collected within 3 min after the end of peripheral intravenous catheterization procedure
evolution of numerical rating scale for anxiety from 0 to 10	data collected just before and within 3 min after peripheral intravenous catheterization procedure	self-evaluation of anxiety catheterization

Trial Locations

Locations (3)

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

CHU; 🇫🇷 Rennes, France

Centre Hospitalier Privé Saint Grégoire; 🇫🇷 Saint Grégoire, France