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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Language and Confusion on Pain During Peripheral Intravenous

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 Summary: 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.
Sponsor: Rennes University Hospital

Current Primary Outcome: 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


Original Primary Outcome: numerical rating scale for pain from 0 to 10 [ Time Frame: data collected at T0, (T0 within 3 min after the end of peripheral intravenous catheterization procedure) ]

self-evaluation of pain catheterization


Current Secondary Outcome:

  • 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
  • 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
  • presence of spontaneous patient arm withdrawal [ Time Frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure ]
  • 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 ]


Original Secondary Outcome:

  • evolution of numerical rating scale for comfort from 0 to 10 [ Time Frame: data collected before and within 3 min after peripheral intravenous catheterization procedure ]
    self-evaluation of comfort catheterization
  • evolution of numerical rating scale for anxiety from 0 to 10 [ Time Frame: data collected before and within 3 min after peripheral intravenous catheterization procedure ]
    self-evaluation of anxiety catheterization
  • presence of spontaneous patient arm withdrawal [ Time Frame: data collected at T0 (T0 within 3 min after the end of peripheral intravenous catheterization procedure) ]
  • presence of unprompted vocalization by word(s) or sound(s) [ Time Frame: data collected at T0 (T0 within 3 min after the end of peripheral intravenous catheterization procedure) ]


Information By: Rennes University Hospital

Dates:
Date Received: January 12, 2016
Date Started: March 2016
Date Completion: June 2017
Last Updated: September 23, 2016
Last Verified: September 2016