- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05306262
Interest of Catalepsy in the Hypnotic Trance (CATALHYPNOANI)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rennes, France
- Institut Emergences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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