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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Delta Nol index ( no unit )
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Prospective monocentric trial randomized to "cross-over". Each subject is its own witness, in the comparison of the analgesic effect of a hypnotherapy session versus a calm waking state, during standardized stimulation with monitoring of the NOL noxious index. As each of the subjects will be subjected to the two aforementioned states, a minimum time of 48 hours will be observed between the two exposures (hypnotherapy or calm watch) to reduce the memorization and the sensitization generated by the thermal stimulation
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers ASA score I, II Age 18 or over
- •Acceptance of protocol and hypnosis in general
- •Good understanding of French
- •Agreement to comply with the recommendations of the protocol Score of the Stanford-Hildegard hypnotisability scale (HGSHS: A) >6
排除标准
- •Psychiatric or neurological pathology making participation in the protocol difficult
- •Drug or alcohol consumption within 24 hours of the evaluation tests and the protocol
- •Analgic consumption within 24 hours before the test (tests and study)
- •Pregnant woman
- •Usual practice of sophrology, hypnosis, or meditation
- •Score of the Stanford-Hildegard hypnotisability scale (HGSHS: A) <6.
研究组 & 干预措施
calm waking group
calm waking state group
干预措施: calm wake group (Other)
hypnosis session
hypnosis session group
干预措施: Medical hypnosis group (Other)
结局指标
主要结局
Delta Nol index ( no unit )
时间窗: From 1 minute before to 5 minutes after the Standard Thermal Stimulation (STS) for each subject
Evaluate in healthy volunteers under hypnosis versus their own control in a calm state the variability of the NOL index (delta-NOL) which is the difference between the value of the peak (average of 3 values around the NOL peak) minus the basal pre-stimulation value, after standardized thermal stimulation
次要结局
- Peak value for NOL (no unit )(from start to 5 minutes after stimulation (STS))
- Aera Under the Curve (AUC) of heart rate (HR ) (unit: beat per minute)(From 1 minute before to 5 minutes after stimulation (STS))
- Peak value of Mean Arterial Blood Pressure (MABP) (unit : mmHg)(From 1 minute before to 5 minutes after stimulation (STS))
- Peak value of Bispectral index ( BIS) ( no unit )(from 1 minute to 5 minutes after stimulation (STS))
- Pain scores (from 0 to 10 ) (no unit)(5 minutes after stimulation (STS))
- Pain perception (yes/no)(5 minutes after stimulation (STS))
- Basal value of NOL index ( no unit )(from 5 minutes to 1 minute before stimulation (STS))
- Area Under the Curve (AUC) of Mean Arterial Blood Pressure (MABP) (unit : mmHg)(From 1 minute before to 5 minutes after stimulation (STS))
- Area Under the Curve) of Bispectral index ( BIS) ( no unit )(from 1 minute to 5 minutes after stimulation (STS))
- Hypnotic transe perception (yes/no)(2 minutes before stimulation (STS))
- Area Under the Curve (AUC) for NOL (no unit)(from start to 5 minutes after stimulation (STS))
- Peak value of heart rate (HR ) (unit: beat per minute)(From 1 minute before to 5 minutes after stimulation (STS))
- Carry over effect (exposition order) (no unit)(from 1 minute before to 5 minutes after stimulation (STS))
- Peak value of NOL index (no unit)(from 1 minute before to 5 minutes after painful suggestion)
- Area Under the Curve (AUC) of NOL index(from 1 minute before to 5 minutes after painful suggestion)
研究者
Philippe Richebe
MD,Ph D ,Professor
Ciusss de L'Est de l'Île de Montréal
