Skip to main content
OpenTrials
Completed

NCT Number: NCT02662322

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anaesthesia Behavior Communication Confusion Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnotic communication

Other

hypnotic communication during peripheral intravenous catheterization

negative connotation communication

Other

negative connotation communication during peripheral intravenous catheterization

neutral connotation communication

Other

neutral connotation communication during peripheral intravenous catheterization

peripheral intravenous catheterization

Other

peripheral intravenous catheterization

Primary outcomes

  1. numerical rating scale for pain from 0 to 10

    Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure

    self-evaluation of pain catheterization

Secondary outcomes

  1. evolution of numerical rating scale for comfort from 0 to 10

    Time frame: data collected just before and within 3 min after peripheral intravenous catheterization procedure

    self-evaluation of comfort catheterization

  2. evolution of numerical rating scale for anxiety from 0 to 10

    Time frame: data collected just before and within 3 min after peripheral intravenous catheterization procedure

    self-evaluation of anxiety catheterization

  3. presence of spontaneous patient arm withdrawal

    Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure

  4. presence of unprompted vocalization by word(s) or sound(s)

    Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Effect of Language and Confusion on Pain During Peripheral Intravenous

Acronym: KTHYPE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2016
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.