Assessment in Healthy Volunteers of the Analgesic Effect Monitored by the NOL Index During Hypnotherapy Session

NCT04802239 | Completed

• 1 other identifier: 2021-2542
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Hypnosis

Keywords

health volunteers; hypnosis; pain; NOL index; Bi spectral index

Outcome Measures

Primary Outcomes (1)

• Delta Nol index ( no unit )

  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

  From 1 minute before to 5 minutes after the Standard Thermal Stimulation (STS) for each subject

Secondary Outcomes (15)

• Basal value of NOL index ( no unit )

  from 5 minutes to 1 minute before stimulation (STS)

• Peak value for NOL (no unit )

  from start to 5 minutes after 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)

• Aera Under the Curve (AUC) of heart rate (HR ) (unit: beat per minute)

  From 1 minute before to 5 minutes after stimulation (STS)

Study Arms (2)

calm waking group

ACTIVE COMPARATOR

calm waking state group

Other: calm wake group

hypnosis session

EXPERIMENTAL

hypnosis session group

Other: Medical hypnosis group

Interventions

Medical hypnosis group OTHER

Hypnotic induction is performed according to a standard protocol and identical for all. A script will be written to give all the important steps. .Only the pleasant place and the characteristics of the analgesic glove will be different between the subjects .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 hypnosis session takes place in safety place , with glove protect by dissociation and confusion techniques.

hypnosis session

calm wake group OTHER

healthy volunteers will observe 3 minutes calm waking state before standardized thermal harmful stimulation

calm waking group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Ph D ,Professor

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 17, 2021
• Study Start: March 8, 2021
• Primary Completion: May 21, 2021
• Study Completion: October 1, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

CA (1)