Prediction of Pain During Old People Care Measured by Ski... | NCT02975778

Studies
Prediction of Pain During Old People Care Measured by Skin Conductance

NCT02975778

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Mar 9, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Pain Monitor™

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-A00709-42	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Budgetary and operational issues

Expanded Access Info

Start Date

Jun 15, 2017Actual

Primary Completion Date

Mar 19, 2018Actual

Completion Date

Mar 19, 2018Actual

First Submitted Date

Nov 24, 2016

First Submission Date that Met QC Criteria

Nov 28, 2016

First Posted Date

Nov 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aged, 65 and over	Experimental		Device: Pain Monitor™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain Monitor™	Device	Pain measured by Pain Monitor™	Aged, 65 and over

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, MD, PhD	Hopital Foch	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maison Médicale Jeanne Garnier		Paris		75015	France
Hopital Foch

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided