Prediction of Pain During Old People Care Measured by Skin Conductance (DOLOAGE)

March 5, 2021 updated by: Hopital Foch

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Maison Médicale Jeanne Garnier
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aged, 65 and over
Device: Pain Monitor™
Pain measured by Pain Monitor™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Anxiety and Depression (HAD) score
Time Frame: 14 days
14 days
Percentage of efficient poses of Pain Monitor
Time Frame: 14 days
14 days
Percentage of patient refusal to use of the Pain monitor
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Study Director: Marc Fischler, MD, PhD, Hôpital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/27
  • 2016-A00709-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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