Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802239
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2021-03-01
Brief Title:
Assessment in Healthy Volunteers of the Analgesic Effect Monitored by the NOL Index During Hypnotherapy Session
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
Assessment in Healthy Volunteers of the Analgesic Effect Monitored by the NOL Index of a Hypnotherapy Session Versus a Calm Waking State During Standardized Thermal Harmful Stimulation The HYPTHENOL Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPTHENOL
Brief 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
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
Detailed 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
iHighly hypnotizable group 10-12 ii Moderately hypnotizable group 7-9 iiiSlightly hypnotizable group 3-6 ivLittle hypnotizable group 0-2 The first two groups score of 7 and more will be included in the experimental studyEvaluation will be carried out according to 2 states over 2 different days with a minimum interval between the two sessions of 48 hoursState of calm watch with thermal stimulation control condition session 1 or 2 depending on randomizationState of hypnotic trance with thermal stimulation and associated with hypnotic analgesic suggestions experimental condition session 1 or 2 depending on randomizationThermal 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 hypnosisThis 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 CThe 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 automaticallySedline 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 subjects forehead These monitors are used in common clinical anesthesia practice and are available and used at HMRThe 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 questionsEven 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 anotherOnly 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 gloveThe 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 suchAn 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 yawningAn 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 ie 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 sessionStatistical planAccording 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 005 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 94 or higher of SAS The level of significance will be set at 005 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 Students 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
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
iHighly hypnotizable group 10-12 ii Moderately hypnotizable group 7-9 iiiSlightly hypnotizable group 3-6 ivLittle hypnotizable group 0-2 The first two groups score of 7 and more will be included in the experimental studyEvaluation will be carried out according to 2 states over 2 different days with a minimum interval between the two sessions of 48 hoursState of calm watch with thermal stimulation control condition session 1 or 2 depending on randomizationState of hypnotic trance with thermal stimulation and associated with hypnotic analgesic suggestions experimental condition session 1 or 2 depending on randomizationThermal 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 hypnosisThis 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 CThe 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 automaticallySedline 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 subjects forehead These monitors are used in common clinical anesthesia practice and are available and used at HMRThe 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 questionsEven 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 anotherOnly 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 gloveThe 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 suchAn 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 yawningAn 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 ie 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 sessionStatistical planAccording 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 005 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 94 or higher of SAS The level of significance will be set at 005 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 Students 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None