NCT02662322

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

January 12, 2016

Last Update Submit

May 4, 2018

Conditions

Anaesthesia

Keywords

CommunicationConfusionIntravenous CatheterizationComfort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • evolution of numerical rating scale for comfort from 0 to 10

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

  • evolution of numerical rating scale for anxiety from 0 to 10

    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

Study Arms (3)

HYPNOSIS

EXPERIMENTAL

hypnotic communication, confusion procedure during peripheral intravenous catheterization

Other: Hypnotic communicationOther: peripheral intravenous catheterization

NOCEBO

ACTIVE COMPARATOR

negative connotation communication during peripheral intravenous catheterization

Other: negative connotation communicationOther: peripheral intravenous catheterization

NEUTRAL

PLACEBO COMPARATOR

neutral connotation communication during peripheral intravenous catheterization

Other: neutral connotation communicationOther: peripheral intravenous catheterization

Interventions

Hypnotic communicationOTHER

hypnotic communication during peripheral intravenous catheterization

HYPNOSIS
negative connotation communicationOTHER

negative connotation communication during peripheral intravenous catheterization

NOCEBO
neutral connotation communicationOTHER

neutral connotation communication during peripheral intravenous catheterization

NEUTRAL
peripheral intravenous catheterizationOTHER

peripheral intravenous catheterization

HYPNOSISNEUTRALNOCEBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • patient unable to communicate in french
  • difficult vein access characteristics
  • premedication
  • pregnant, breast-feeding woman
  • patient subject of legal protection

You may not qualify if:

  • failed of the first attempt of peripheral intravenous catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cliniques Universitaires Saint-Luc

Brussels, 10 1200, Belgium

Location

CHU

Rennes, 35033, France

Location

Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, 35768, France

Location

Related Publications (1)

  • 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.

    PMID: 31862159DERIVED

MeSH Terms

Conditions

CommunicationConfusion

Condition Hierarchy (Ancestors)

BehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helene Beloeil, PH

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 25, 2016

Study Start

March 10, 2016

Primary Completion

March 6, 2017

Study Completion

September 6, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)BE(1)