Prediction of Pain During Old People Care Measured by Skin Conductance

Pain Clinical Trial

— DOLOAGE  

Official title:

Prediction of Pain During Old People Care Measured by Skin Conductance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975778
• Other study ID #: 2016/27
• Secondary ID: 2016-A00709-42
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: March 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Pain Monitor™
Pain measured by Pain Monitor™

Locations

Country	Name	City	State
France	Maison Médicale Jeanne Garnier	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital Anxiety and Depression (HAD) score		14 days
Secondary	Percentage of efficient poses of Pain Monitor		14 days
Secondary	Percentage of patient refusal to use of the Pain monitor		14 days