Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04802239 |
| Other study ID # |
2021-2542 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 8, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Ciusss de L'Est de l'Île de Montréal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
to evaluate, in healthy volunteers, the analgesic effect of medical hypnosis versus a state
of calm watch during a thermal harmful stimulation and monitored by a quantitative, objective
criterion and validated in the literature that is the NOL index .Monitoring the NOL index
will allow us to assess the level of nocipception linked to standardized thermal stimulation
between the two states: hypnotherapy versus calm watch state. Each subject of the study will
be subject to the two conditions (hypnosis versus calm watch state) during which participant
will be subjected to the same type of thermal stimulation with the same monitoring of the
parameters under study.
The choice, for each subject, to start with the hypnosis session versus the calm standby
session will be decided by randomization according to the "cross-over" drawing of this study,
and before session 1.
Using the NOL index, the investigators want to check what is the real and objective impact of
hypnosis on the pain induced by a standardized harmful stimulus.
If the investigators find a significant difference in the variations of the NOL index after
harmful stimulation between the two situations (hypnosis versus calm watch state) then the
investigators can offer this monitoring in future studies, to follow the induced hypnotic
trance in patients with local anesthesia during surgery associated with hypnosedation.
Description:
Study desing: Monocentric, prospective randomized test in "crossover" (each subject being its
own witness), comparing the analgesic effect of a hypnotherapy session versus a calm standby
state.
Population studied: Healthy volunteers, adults Sample size: 12 subjects will be included in
total, each one being subjected to the two sessions with different conditions (hypnosis
versus calm watch state) subjects will be evaluated and classified by the hypnotisability
score of the Harvard group scale of hypnotic susceptibility form A (HGSHS: A) translated into
French by Hernan A and J Becchio
Participants will be classified into 4 groups :
i)Highly hypnotizable group (10-12), ii) Moderately hypnotizable group (7-9) iii)Slightly
hypnotizable group (3-6) iv)Little hypnotizable group (0-2) The first two groups (score of 7
and more) will be included in the experimental study.Evaluation will be carried out according
to 2 states over 2 different days, with a minimum interval between the two sessions of 48
hours.State of calm watch with thermal stimulation = control condition (session 1 or 2
depending on randomization).State of hypnotic trance with thermal stimulation and associated
with hypnotic analgesic suggestions = experimental condition (session 1 or 2 depending on
randomization).Thermal stimulation is performed using a Thermo Q-sense thermal probe (Medoc
Advanced Medical Systems, Israel). The probe will first be calibrated before contact with the
subject. Then, the probe will be placed on the palm side of the left hand for all subjects
and during the two sessions (calm and hypnosis).This probe has already been used by our team
for other research work and is completely safe, causing no skin damage to the subject. The
Department of Anesthesiology and Pain Medicine owns this device. The temperature varies
between 30 ° to 50 ° C in about 30 seconds, and stops under three conditions: when the
subject clicks on a controller, at his requests, or when this temperature reaches 50 ° C.The
NOL index: the NOL will be recorded continuously through the PMD200TM monitor, available at
HMR in current clinical practice of anesthesia. Registration will begin at the start of
sessions and procedures. PMD200TM also records heart rate values automatically.Sedline (EEG
monitor peranesthesia, Masimo, CA, USA) will also be connected to the subject to assess the
spectrogram of EEG waves (electroencephalography) with or without hypnosis. This monitor is
non-invasive and gives its parameters using an electrode that sticks to the subject's
forehead. These monitors are used in common clinical anesthesia practice and are available
and used at HMR.The data will be electronically exported at the end of the experiment in a
completely anonymous manner and kept in confidential, anonymous and protected electronic
files of the study for a period of 7 years.
A pre-hypnosis consultation with the subjects will take place just before the session in
order to harvest a place of safety and , assess its major communication channel, collect
useful information for the realization of the "analgesic glove", establish a signal with him
to rule on the state of trance and answer their questions.Even if the protocol is standard in
its design, the protocol remains specific to each participant and adapted to the place of
"safe place" and / or to the characteristics of the protective glove or "analgesic glove"
that participant has chosen.
A formal hypnosis session will be conducted on the theme of a safety location chosen by the
subject. When the trance is confirmed, the investigators will carry out the thermal
stimulation starting at 30 ° C, and increasing the temperature until the stop requested by
the subject (via a controller, or by its request). To stay safe, stimulation by this thermal
probe cannot exceed 50 ° C over 30 seconds, and therefore cannot cause any burn. The
technique of "antalgic suggestion" will be done through a protective glove and an analgesic
cream, which will modulate the pain. Hypnotic induction is performed according to a standard
protocol and identical for all. A script will be written to give all the important steps.
This is a semi-structured hypnosis which will follow an identical pattern from one subject to
another.Only the pleasant place and the characteristics of the analgesic glove will be
different between the subjects because they are personal choices. This is important to keep a
permissiveness in hypnosis and to adapt it to each subject according to the recommendations
of permissive hypnosis.
the procedure will follow the following protocol:
- State of calm at rest of 3 minutes.- Hypnotic induction by catalepsy of the eyes guided
by breathing.- The interview takes place in a place of safety, or leisure activity by
dissociation and confusion techniques.- The place of security, this activity will be
specific to each subject and will be personal.
- The analgesic suggestion will be made through a "protective glove".The hypnotic state
will be considered to have been reached when the subject indicates it to the clinician
using a previously installed signal and in response to three questions: "Are
participants comfortable where they are ?"; "Did participants put the glove and the
cream right on their hand ?";" Is the hand well protected ?".The hypnotic state is
affirmed if the subject answers "yes" to the 3 questions. If the comfort of the subject
is not satisfactory, the therapist will deepen the hypnotic trance with other
suggestions, and will wait for the time necessary for the subject to reach this state.
If, despite this, the subject cannot reach the desired state, the subject will be
classified as resistant and will be analyzed as such.An objective evaluation of the
trance signs will be made by an outside observer to note the presence or not of the
following signs - immobility of the body- respiratory slowdown- slowdown in movements-
slowing of responses and ideas: slowness of speech, and altered voice- variation in face
color: pallor, redness- relaxed face muscles- modification of the overall muscle tone-
gaze fixed- modified swallowing: slowed or accentuated- awakening behaviors at the end
of the trance: blinking, rubbing of the eyes, yawning.An evaluation of the
perception-pain score will be made with the subject at the end of the session: P0: no
perception or pain, P1: perception but no pain, P2: perception and average pain, P3:
perception and pain present, P4: severe pain perception
Regarding the "control" condition, i.e. without hypnosis :
- These are the same subjects of the study. - Participants will be put in a calm standby
situation, at rest, in a dorsal decubitus, eyes closed for at least 3 minutes.
- The probe will deliver an increasing thermal intensity starting from 30 ° to a safe
maximum of 50 ° in 30 seconds too.- An identical evaluation of the perception-pain score
will be made with the participant at the end of the session.Statistical plan:According
to previous studies carried out in our department, the variation of the NOL (delta-NOL)
index following a harmful stimulation without analgesics is approximately 15 +/- 5. The
use of an analgesic such as N2O made it possible to reduce this delta-NOL by
approximately 35% (Richebé et al., in press in European Journal of Anaesthesia).
Believing that hypnotherapy could also reduce this delta-NOL by 40%, with an alpha to 0.05
and a power of 80% and a bilateral test, the number of subjects necessary to meet our main
objective will be 12. The investigators do not expect a loss in follow-up during this study
on healthy voluntary subjects. The investigators will therefore include a total of 12
participants who will have scanned> 6 on the aforementioned hypnotisability scale during
screening.
Data analyzes :
Statistical analyzes will be carried out using version 9.4 or higher of SAS. The level of
significance will be set at 0.05 bilaterally, unless otherwise indicated. Continuous data
will be expressed on average or median with the appropriate dispersion index (standard
deviation (SD) or interquartile range). The categorical data will be expressed in number with
proportion. Confidence intervals (CI) will be expressed at a level of 95%. The normal
distribution of continuous variables will be assessed using the Shapiro-Wilk test. The
comparison of these variables will be carried out using Student's t test if the distribution
is normal and using the Mann-Whitney non-parametric test otherwise. The categorical variables
will be analyzed using the Khi-two test when the number of subjects in all groups is ≥ 5 and
using the exact Fisher test otherwise.
