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

Anaesthesia Clinical Trial

— KTHYPE  

Official title:

Effect of Language and Confusion on Pain During Peripheral Intravenous

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662322
• Other study ID #: 35RC15_9868
• Status: Completed
• Phase: N/A
• Start date: March 10, 2016
• Est. completion date: September 6, 2017

Study information

• Verified date: May 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: September 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia
• Confusion

Intervention

Other:
• Hypnotic communication
hypnotic communication during peripheral intravenous catheterization
• negative connotation communication
negative connotation communication during peripheral intravenous catheterization
• neutral connotation communication
neutral connotation communication during peripheral intravenous catheterization
• peripheral intravenous catheterization
peripheral intravenous catheterization

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
France	CHU	Rennes
France	Centre Hospitalier Privé Saint Grégoire	Saint Grégoire

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	presence of spontaneous patient arm withdrawal		data collected within 3 min after the end of peripheral intravenous catheterization procedure
Secondary	presence of unprompted vocalization by word(s) or sound(s)		data collected within 3 min after the end of peripheral intravenous catheterization procedure