- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421562
Training Nurses in Basic Hypnoanalgesia Techniques (HYPNO-DIS)
April 15, 2015 updated by: Michel Duval, St. Justine's Hospital
Training Nurses in Basic Hypnoanalgesia Techniques to Reduce Procedural Distress and Pain in Children: a Pilot Study
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- Ste-Justine Hospital
-
Contact:
- Terry Mizrahi, MD
- Phone Number: 3996 +1 514 345 49 31
- Email: terry.mizrahi@gmail.com
-
Contact:
- Michel Duval, MD
- Phone Number: 6746 +1 514 345 49 31
- Email: michel.duval@umontreal.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: training in hypnoanalgesia
training nurses in hypnoanalgesia to perform painful procedure in children
|
training nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale).
Time Frame: 12 months
|
12 months
|
|
Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Duval, MD, Ste-Justine Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
April 12, 2015
First Submitted That Met QC Criteria
April 15, 2015
First Posted (Estimate)
April 20, 2015
Study Record Updates
Last Update Posted (Estimate)
April 20, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- HYPNO-DIS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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