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

Effect of Language and Confusion on Pain During Peripheral Intravenous

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02662322
Acronym
KTHYPE
Enrollment
294
Registered
2016-01-25
Start date
2016-03-10
Completion date
2017-09-06
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

Communication, Confusion, Intravenous Catheterization, Comfort

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.

Interventions

hypnotic communication during peripheral intravenous catheterization

OTHERnegative connotation communication

negative connotation communication during peripheral intravenous catheterization

OTHERneutral connotation communication

neutral connotation communication during peripheral intravenous catheterization

peripheral intravenous catheterization

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
numerical rating scale for pain from 0 to 10data collected within 3 min after the end of peripheral intravenous catheterization procedureself-evaluation of pain catheterization

Secondary

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

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026