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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05306262
Other study ID # 2020/03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2022
Est. completion date May 28, 2022

Study information

Verified date June 2022
Source CMC Ambroise Paré
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Catalepsy seems to facilitate hypnotic induction and deepen hypnotic trance, although no work confirms the usefulness of this technique which is in common use in hypnosis. Furthermore, it has been shown that the hypnotic trance state is accompanied by an increase in parasympathetic tone, the non-invasive measurement of which is easy by the ANI monitor (Analgesia Nociception Index). The research hypothesis is that, by adding a body dissociation, catalepsy could facilitate and intensify the hypnotic trance, the intensity of which can be monitored and is proportional to the parasympathetic tone.


Description:

After randomization, subjects will either benefit from the normal hypnotic trance, or from the hypnotic trance associated with catalepsy of the hand. T0 = installation in a sitting position and collection of an accompanying theme T1 = induction of the hypnotic trance (closing eyes) with restitution of the theme to the patient and suggestion of comfort over a period of 5 to 10 min T2 = validation of comfort by a pre-established signal T3 = return to consciousness (opening eyes) T4 = end of questionnaire about absorption, dissociation and time perception


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 28, 2022
Est. primary completion date May 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Healthy Volunteers - Consent for participation - Affiliation to the social security system Exclusion Criteria: - Arrhythmia (atrial fibrillation, pacemaker, defibrillator) - Autonomic nervous system disorder (paraplegia, epilepsy, etc.) - Pregnant or breastfeeding woman - Patients under protection of the adults (guardianship, curators or safeguard of justice) - Communication difficulties

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hypnosis session
Comfort hypnosis: accompaniment of a pleasant memory.
Other:
Catalepsy
Catalepsy of the hand.

Locations

Country Name City State
France Institut Emergences Rennes

Sponsors (1)

Lead Sponsor Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parasympathetic tone Analgesia Nociception Index (ANI) 30 minutes
Secondary Absorption Numeric scale from 0 to 10 (0=not at all, 10=completely) 30 minutes
Secondary Dissociation Numeric scale from 0 to 10 (0=completely in the reality, 10=completely disconnected from reality) 30 minutes
Secondary Time perception (minute) Difference between the time of hypnosis session estimated by the patient and the actual time of hypnosis session (from closing to opening the eyes). 30 minutes
Secondary Variation of Heart Rate (beat per minute) Heart rate measured by a pulse oximeter 30 minutes
Secondary Variation of Respiratory Rate (breath per minute) Respiratory rate assessed by the investigator 30 minutes
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