NCT02975778

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

November 24, 2016

Last Update Submit

March 5, 2021

Conditions

Pain

Keywords

65 years old

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

Study Arms (1)

Aged, 65 and over

EXPERIMENTAL
Device: Pain Monitor™

Interventions

Pain Monitor™DEVICE

Pain measured by Pain Monitor™

Aged, 65 and over

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maison Médicale Jeanne Garnier

Paris, 75015, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Fischler, MD, PhD

    Hopital Foch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

June 15, 2017

Primary Completion

March 19, 2018

Study Completion

March 19, 2018

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)