- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02971852
Effects of Hypnosis on Skin Temperature
Hypnotic Glove Anesthesia: Effects of Hypnosis on Skin Temperature Measured by Infrared Thermography
Study Overview
Status
Conditions
Detailed 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A last record of skin temperature in both hands is performed 5 min after the glove is withdrawn (T4).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rennes, France, 35000
- Institut Emergences
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Saint-Grégoire, France, 35768
- Centre Hospitalier Prive Saint-Gregoire
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Soyaux, France, 16800
- Centre Clinical
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skin temperature during the experiment in the hand and forearm
Time Frame: 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).
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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.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity during the experiment following noxious stimulation
Time Frame: 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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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).
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xavier Paqueron, MD, PhD, Centre Clinical, France
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Hypnotic glove anesthesia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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