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TerminatedNCT02975778DOLOAGEUpdated Mar 9, 2021

Prediction of Pain During Old People Care Measured by Skin Conductance

An interventional study of Pain Monitor™ in Pain, sponsored by Hopital Foch. Terminated at 2 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Hopital Foch · Not applicable, Interventional, and Prevention

Why this study was terminated
Budgetary and operational issues
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • 65 years old
03

In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • cutaneous anomaly on the site of measure;
  • pacemaker or internal defibrillator;
  • extremities twitching;
  • Treated by neostigmine.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Aged, 65 and over

    Device: Pain Monitor™

Interventions

  • DevicePain Monitor™

    Pain measured by Pain Monitor™

06

What researchers measure

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

    Time frame: 14 days

Secondary outcomes

  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

07

Study locations

2 sites
  • Maison Médicale Jeanne Garnier
    Paris, 75015, France
  • Hopital Foch
    Suresnes, 92150, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02975778
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
Jun 15, 2017
Primary completion
Mar 19, 2018
Completion
Mar 19, 2018
Last update
Mar 9, 2021

Study contacts

Marc Fischler, MD, PhD
study director · Hopital Foch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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