MedTrace Logo

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

NCT04802239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-04

No results posted yet for this study

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

Interventions

OTHER

Medical hypnosis group

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.

OTHER

calm wake group

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-05-21
Completion
2021-10-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802239 on ClinicalTrials.gov