NCT02971852

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

November 15, 2016

Last Update Submit

July 18, 2017

Conditions

HypnosisHealthy Volunteers

Keywords

HypnosisAnesthesiaSuggestionThermography

Outcome Measures

Primary Outcomes (1)

  • 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20 min installation and temperature equilibration, to the end of the experiment, 5 min after the glove is mentally withdrawn (approximately 1 h).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 Outcomes (1)

  • Change in pain intensity during the experiment following noxious stimulation

    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from 10 min after the beginning of the experiment to 5 min before the end of the experiment, when the glove is mentally withdrawn (approximately 45 min).

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Healthy volunteers aged from 18 to 75

You may not qualify if:

  • Neurologic or psychiatric disorder
  • Upper limb amputation
  • Microcirculation abnormalities (e.g. Raynaud syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Émergences

Rennes, 35000, France

Location

Centre hospitalier privé Saint-Grégoire

Saint-Grégoire, 35768, France

Location

Centre Clinical

Soyaux, 16800, France

Location

Study Officials

  • Xavier Paqueron, MD, PhD

    Centre Clinical, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)