HypnosisNCT02971852
Effects of Hypnosis on Skin Temperature
An observational study of Hypnosis and Healthy Volunteers, run by Claude Bernard University at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypnosis, Healthy Volunteers
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy volunteers aged from 18 to 75
Who cannot join
- Neurologic or psychiatric disorder
- Upper limb amputation
- Microcirculation abnormalities (e.g. Raynaud syndrome)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Émergences
Rennes, 35000
Centre hospitalier privé Saint-Grégoire
Saint-Grégoire, 35768
Centre Clinical
Soyaux, 16800
About this study
Official title: Hypnotic Glove Anesthesia: Effects of Hypnosis on Skin Temperature Measured by Infrared Thermography
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.
Read the 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).
- Conditions
- Hypnosis, Healthy Volunteers
- Keywords
- Hypnosis, Anesthesia, Suggestion, Thermography
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Clinical, France, Saint-Gregoire Private Hospital Center, Institut Émergences, France
- Responsible party
- Principal investigator, Emmanuel Boselli, Claude Bernard University
- Investigators
- Xavier Paqueron, MD, PhD, Principal investigator, Centre Clinical, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971852
- Sponsor's protocol ID
- Hypnotic glove anesthesia
- Status last verified
- Jul 2017
- First submitted
- 15 Nov 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotic Glove Anesthesia: Effects of Hypnosis on Skin Temperature Measured by Infrared Thermography
- ClinicalTrials.gov ID
- NCT02971852
- Acronym / sponsor ID
- Hypnotic glove anesthesia
- Conditions
- Hypnosis, Healthy Volunteers
- Keywords
- Hypnosis, Anesthesia, Suggestion, Thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Collaborators
- Centre Clinical, France, Saint-Gregoire Private Hospital Center, Institut Émergences, France
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- Healthy volunteers aged from 18 to 75
Key exclusion criteria (3 listed)
- Neurologic or psychiatric disorder
- Upper limb amputation
- Microcirculation abnormalities (e.g. Raynaud syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Paqueron, MD, PhD principal investigator
Centre Clinical, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypnosis and Healthy Volunteers, run by Claude Bernard University at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.