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

Effect of Language and Confusion on Pain During Peripheral Intravenous

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).

Study Overview

• Status: Completed
• Conditions: Anaesthesia
• Intervention / Treatment: Other: Hypnotic communication; Other: peripheral intravenous catheterization; Other: negative connotation communication; Other: neutral connotation communication

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.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 10 1200
    • Cliniques Universitaires Saint-Luc
• France
  • Rennes, France, 35033
    • CHU
  • Saint Grégoire, France, 35768
    • Centre Hospitalier Privé Saint Grégoire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HYPNOSIS; hypnotic communication, confusion procedure during peripheral intravenous catheterization	Other: Hypnotic communication; hypnotic communication during peripheral intravenous catheterization; Other: peripheral intravenous catheterization; peripheral intravenous catheterization
Active Comparator: NOCEBO; negative connotation communication during peripheral intravenous catheterization	Other: peripheral intravenous catheterization; peripheral intravenous catheterization; Other: negative connotation communication; negative connotation communication during peripheral intravenous catheterization
Placebo Comparator: NEUTRAL; neutral connotation communication during peripheral intravenous catheterization	Other: peripheral intravenous catheterization; peripheral intravenous catheterization; Other: neutral connotation communication; neutral connotation communication during peripheral intravenous catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
presence of spontaneous patient arm withdrawal		data 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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Helene Beloeil, PH, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2016
• Primary Completion (Actual): March 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Confusion; Communication; Comfort; Intravenous Catheterization
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Confusion; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 35RC15_9868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No