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

Primary Purpose

Anaesthesia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hypnotic communication
negative connotation communication
neutral connotation communication
peripheral intravenous catheterization
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anaesthesia focused on measuring Communication, Confusion, Intravenous Catheterization, Comfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • CHU
  • Centre Hospitalier Privé Saint Grégoire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

HYPNOSIS

NOCEBO

NEUTRAL

Arm Description

hypnotic communication, confusion procedure during peripheral intravenous catheterization

negative connotation communication during peripheral intravenous catheterization

neutral connotation communication during peripheral intravenous catheterization

Outcomes

Primary Outcome Measures

numerical rating scale for pain from 0 to 10
self-evaluation of pain catheterization

Secondary Outcome Measures

evolution of numerical rating scale for comfort from 0 to 10
self-evaluation of comfort catheterization
evolution of numerical rating scale for anxiety from 0 to 10
self-evaluation of anxiety catheterization
presence of spontaneous patient arm withdrawal
presence of unprompted vocalization by word(s) or sound(s)

Full Information

First Posted
January 12, 2016
Last Updated
May 4, 2018
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02662322
Brief Title
Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)
Acronym
KTHYPE
Official Title
Effect of Language and Confusion on Pain During Peripheral Intravenous
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
March 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaesthesia
Keywords
Communication, Confusion, Intravenous Catheterization, Comfort

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HYPNOSIS
Arm Type
Experimental
Arm Description
hypnotic communication, confusion procedure during peripheral intravenous catheterization
Arm Title
NOCEBO
Arm Type
Active Comparator
Arm Description
negative connotation communication during peripheral intravenous catheterization
Arm Title
NEUTRAL
Arm Type
Placebo Comparator
Arm Description
neutral connotation communication during peripheral intravenous catheterization
Intervention Type
Other
Intervention Name(s)
Hypnotic communication
Intervention Description
hypnotic communication during peripheral intravenous catheterization
Intervention Type
Other
Intervention Name(s)
negative connotation communication
Intervention Description
negative connotation communication during peripheral intravenous catheterization
Intervention Type
Other
Intervention Name(s)
neutral connotation communication
Intervention Description
neutral connotation communication during peripheral intravenous catheterization
Intervention Type
Other
Intervention Name(s)
peripheral intravenous catheterization
Intervention Description
peripheral intravenous catheterization
Primary Outcome Measure Information:
Title
numerical rating scale for pain from 0 to 10
Description
self-evaluation of pain catheterization
Time Frame
data collected within 3 min after the end of peripheral intravenous catheterization procedure
Secondary Outcome Measure Information:
Title
evolution of numerical rating scale for comfort from 0 to 10
Description
self-evaluation of comfort catheterization
Time Frame
data collected just before and within 3 min after peripheral intravenous catheterization procedure
Title
evolution of numerical rating scale for anxiety from 0 to 10
Description
self-evaluation of anxiety catheterization
Time Frame
data collected just before and within 3 min after peripheral intravenous catheterization procedure
Title
presence of spontaneous patient arm withdrawal
Time Frame
data collected within 3 min after the end of peripheral intravenous catheterization procedure
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Beloeil, PH
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
10 1200
Country
Belgium
Facility Name
CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Privé Saint Grégoire
City
Saint Grégoire
ZIP/Postal Code
35768
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31862159
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.
Results Reference
derived

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

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