Prediction of Pain During Old People Care Measured by Skin Conductance

NCT ID: NCT02975778

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-03-19

Brief Summary

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The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity.

The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aged, 65 and over

Group Type EXPERIMENTAL

Pain Monitor™

Intervention Type DEVICE

Pain measured by Pain Monitor™

Interventions

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Pain Monitor™

Pain measured by Pain Monitor™

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* hospitalized patient;
* patient over 65 years of age;
* communicating, without cognitive impairment;
* having to undergo an act presumed to be painful during which the patient's mobility is limited: nursing care (removal of a drain, dressing of a chronic wound, urinary catheterization, etc.), medical examination, etc.;
* benefiting from a social security scheme or having rights;
* having given their prior informed written consent;
* person able to read.

Exclusion Criteria

* cutaneous anomaly on the site of measure;
* pacemaker or internal defibrillator;
* extremities twitching;
* Treated by neostigmine.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD, PhD

Role: STUDY_DIRECTOR

Hopital Foch

Locations

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Maison Médicale Jeanne Garnier

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00709-42

Identifier Type: OTHER

Identifier Source: secondary_id

2016/27

Identifier Type: -

Identifier Source: org_study_id

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