Prediction of Pain During Old People Care Measured by Skin Conductance

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Device: Pain Monitor™

• Registration Number: NCT02975778
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Study Start: 2017-06-15
• Primary Completion: 2018-03-19
• Study Completion: 2018-03-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aged, 65 and over	Pain Monitor™	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression (HAD) score	14 days
Percentage of efficient poses of Pain Monitor	14 days
Percentage of patient refusal to use of the Pain monitor	14 days

Trial Locations

Locations (2)

Maison Médicale Jeanne Garnier; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France