Interest of Catalepsy in the Hypnotic Trance (CATALHYPNOANI)

June 23, 2022 updated by: CMC Ambroise Paré

Effects of Catalepsy on the Parasympathetic Tone Assessed by ANI (Analgesia/Nociception Index) and on Absorption, Dissociation and Perception of Time During the Hypnotic Trance.

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rennes, France
        • Institut Emergences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hypnotic trance
Hypnosis session of comfort for 20 minutes
Comfort hypnosis: accompaniment of a pleasant memory.
Experimental: hypnotic trance + catalepsy
Catalepsy + Hypnosis session of comfort for 20 minutes
Comfort hypnosis: accompaniment of a pleasant memory.
Catalepsy of the hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasympathetic tone
Time Frame: 30 minutes
Analgesia Nociception Index (ANI)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorption
Time Frame: 30 minutes
Numeric scale from 0 to 10 (0=not at all, 10=completely)
30 minutes
Dissociation
Time Frame: 30 minutes
Numeric scale from 0 to 10 (0=completely in the reality, 10=completely disconnected from reality)
30 minutes
Time perception (minute)
Time Frame: 30 minutes
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
Variation of Heart Rate (beat per minute)
Time Frame: 30 minutes
Heart rate measured by a pulse oximeter
30 minutes
Variation of Respiratory Rate (breath per minute)
Time Frame: 30 minutes
Respiratory rate assessed by the investigator
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Actual)

May 28, 2022

Study Completion (Actual)

May 28, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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