NCT02421562

Brief Summary

Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia techniques, and this new tool will translate into a reduction of procedural distress and pain in their patients, thereby opening the way to larger clinical trials in various pediatric settings.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

April 12, 2015

Last Update Submit

April 15, 2015

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Practice performance of pediatric nurses after a 4-day training in hypnonalgesia techniques. Practice performance will be evaluated by two external evaluators on videotapes using a standardized scale.

    12 months

Secondary Outcomes (2)

  • Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale).

    12 months

  • Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings.

    12 months

Study Arms (1)

training in hypnoanalgesia

EXPERIMENTAL

training nurses in hypnoanalgesia to perform painful procedure in children

Procedure: training in hypnoanalgesia

Interventions

training in hypnoanalgesiaPROCEDURE

training nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic

training in hypnoanalgesia

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children followed in the hematology-oncology outpatient clinic at least 4 times per year
  • good understanding in French
  • use of topic anesthesia or distraction object allowed, as long as used at all venipuncture measured sessions

You may not qualify if:

  • prior use of hypnoanalgesia
  • patients coming for emergency or non-scheduled appointment
  • patients with acute pain on their scheduled appointment to the clinic
  • acute psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ste-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Michel Duval, MD

    Ste-Justine Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Terry Mizrahi, MD

CONTACT

+1 514 345 4931terry.mizrahi@gmail.com

Michel Duval, MD

CONTACT

+1 514 345 4931michel.duval@umontreal.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Michel Duval, MD

Study Record Dates

First Submitted

April 12, 2015

First Posted

April 20, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

CA(1)