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Trial record 22 of 81692 for:    measured

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

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ClinicalTrials.gov Identifier: NCT02975778
Recruitment Status : Terminated (Budgetary and operational issues)
First Posted : November 29, 2016
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Device: Pain Monitor™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prediction of Pain During Old People Care Measured by Skin Conductance
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Arm Intervention/treatment
Experimental: Aged, 80 and over Device: Pain Monitor™
Pain measured by Pain Monitor™




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Hospital Anxiety and Depression (HAD) score [ Time Frame: 14 days ]
  2. Percentage of efficient poses of Pain Monitor [ Time Frame: 14 days ]
  3. Percentage of patient refusal to use of the Pain monitor [ Time Frame: 14 days ]


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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patient
  • over 80 years old
  • communicating, trouble-free cognitive;
  • that must undergo a painful presumed act in the course of which the mobility of the patient is limited: nursing care (ablation of drain, bandage of a chronic wound, an urinary poll, …), medical examination, … ;
  • benefiting from a social security scheme or beneficiary;
  • having given a written informed consent ;
  • able to read

Exclusion Criteria:

  • cutaneous anomaly on the site of measure;
  • pacemaker or internal defibrillator;
  • extremities twitching;
  • Treated by neostigmine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975778


Locations
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France
Maison Médicale Jeanne Garnier
Paris, France, 75015
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Study Director: Marc Fischler, MD, PhD Hopital Foch

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02975778     History of Changes
Other Study ID Numbers: 2016/27
2016-A00709-42 ( Other Identifier: ANSM )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hopital Foch:
80 years old