Clinical trial NCT02662322: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)
Official title: Effect of Language and Confusion on Pain During Peripheral Intravenous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Keywords: Communication
Confusion
Intravenous Catheterization
Comfort
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: numerical rating scale for pain from 0 to 10
timeFrame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
Secondary outcomes:
measure: evolution of numerical rating scale for comfort from 0 to 10
timeFrame: data collected just before and within 3 min after peripheral intravenous catheterization procedure
measure: evolution of numerical rating scale for anxiety from 0 to 10
timeFrame: data collected just before and within 3 min after peripheral intravenous catheterization procedure
measure: presence of spontaneous patient arm withdrawal
timeFrame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
measure: presence of unprompted vocalization by word(s) or sound(s)
timeFrame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Rennes
country: France
facility: CHU
city: Saint Grégoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire
Study officials:
affiliation: Rennes University Hospital
name: Helene Beloeil, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18.