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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02971852
Other study ID # Hypnotic glove anesthesia
Secondary ID
Status Completed
Phase N/A
First received November 15, 2016
Last updated July 18, 2017
Start date November 2016
Est. completion date March 2017

Study information

Verified date July 2017
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas of the hand that would be covered by a glove. We investigated the effects of hypnotic glove anesthesia on skin temperature measured by thermography.


Description:

After 20 min installation and temperature equilibration (T0), the subject skin temperature was recorded in 5 regions of both hands (1 = distal hand, 2 = proximal hand, 3 = wrist, 4 = distal forearm, 5 = proximal forearm) using infrared thermography.

After 10 min of latency, skin temperature was recorded again in both hands (T1).

A first noxious stimulus (NOX1) is then applied by the hypnotherapist by pinching the webbing between the thumb and index fingers of the dominant hand between the thumb and the index. Pain intensity is assessed on a 0-10 (0 = no pain, 10 = maximal pain imaginable) numerical rating scale (NRS1).

The hypnotic glove is then mentally created by the subject on his dominant hand following the suggestions of the hypnotherapist (T2). To assess the efficacy of the hypnotic glove, a second noxious stimulus (NOX2) is applied similarly to NOX1 and the NRS was recorded (NRS2).

The subject is then invited to mentally wear off the glove (T3). Skin temperature is then recorded in both hands, and a third noxious stimulus (NOX3) is applied similarly to NOX1 and NOX2 to verify the disappearance of hypnotic anesthesia.

A last record of skin temperature in both hands is performed 5 min after the glove is withdrawn (T4).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy volunteers aged from 18 to 75

Exclusion Criteria:

- Neurologic or psychiatric disorder

- Upper limb amputation

- Microcirculation abnormalities (e.g. Raynaud syndrome)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Institut Émergences Rennes
France Centre hospitalier privé Saint-Grégoire Saint-Grégoire
France Centre Clinical Soyaux

Sponsors (4)

Lead Sponsor Collaborator
Claude Bernard University Centre Clinical, France, Centre hospitalier privé Saint-Grégoire, France, Institut Émergences, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in skin temperature during the experiment in the hand and forearm Comparison of skin temperature between the dominant ("wearing" the hypnotic glove) and the non-dominant hand and forearm in the 5 predefined regions from Time 0 to Time 4. During the study experiment, from the beginning of the experiment, after 20 min installation and temperature equilibration, to the end of the experiment, 5 min after the glove is mentally withdrawn (approximately 1 h).
Secondary Change in pain intensity during the experiment following noxious stimulation Comparison of pain intensity following noxious stimulation assessed by 0-10 NRS scale at Time 1, Time 2 and Time 3 in the dominant hand ("wearing" the hypnotic glove). During the study experiment, from 10 min after the beginning of the experiment to 5 min before the end of the experiment, when the glove is mentally withdrawn (approximately 45 min).
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