CancerHYPNO-DISNCT02421562
Training Nurses in Basic Hypnoanalgesia Techniques
A study testing training in hypnoanalgesia in people with Cancer, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- training in hypnoanalgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ste-Justine Hospital
Montreal, Quebec, H3T 1C5
Terry Mizrahi, MD, +1 514 345 49 31 ext. 3996, terry.mizrahi@gmail.com
Michel Duval, MD, +1 514 345 49 31 ext. 6746, michel.duval@umontreal.ca
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- training in hypnoanalgesia
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training in hypnoanalgesiaProcedure or surgery
training nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic
| Study group | Role | What they receive |
|---|---|---|
| training in hypnoanalgesia | Experimental | training nurses in hypnoanalgesia to perform painful procedure in children Receives: Procedure: training in hypnoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale).
Measured: 12 months
Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Duval, St. Justine's Hospital
- Investigators
- Michel Duval, MD, Principal investigator, Ste-Justine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421562
- Sponsor's protocol ID
- HYPNO-DIS
- Acronym
- HYPNO-DIS
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2015
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Nurses in Basic Hypnoanalgesia Techniques to Reduce Procedural Distress and Pain in Children: a Pilot Study
- ClinicalTrials.gov ID
- NCT02421562
- Acronym / sponsor ID
- HYPNO-DIS / HYPNO-DIS
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| training in hypnoanalgesia | Experimental | Procedure: training in hypnoanalgesiatraining nurses in hypnoanalgesia to perform painful procedure in children |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training in hypnoanalgesiatraining nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic | Procedure or surgery | training in hypnoanalgesia |
Primary outcome
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
2 secondary outcomes
Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale).
Time frame: 12 months
Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Duval, MD principal investigator
Ste-Justine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in hypnoanalgesia in people with Cancer, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terry Mizrahi, MD (+1 514 345 4931 ext. 3996, terry.mizrahi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.