PainDOLOAGENCT02975778
Prediction of Pain During Old People Care Measured by Skin Conductance
A study testing Pain Monitor™ in people with Pain, run by Hopital Foch at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain Monitor™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2017to 19 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- cutaneous anomaly on the site of measure;
- pacemaker or internal defibrillator;
- extremities twitching;
- Treated by neostigmine.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maison Médicale Jeanne Garnier
Paris, 75015
Hopital Foch
Suresnes, 92150
About this study
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.
- Conditions
- Pain
- Being tested
- Pain Monitor™
- Keywords
- 65 years old
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Monitor™Device
Pain measured by Pain Monitor™
| Study group | Role | What they receive |
|---|---|---|
| Aged, 65 and over | Experimental | Not described Receives: Device: Pain Monitor™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain
Measured: 14 days
Secondary outcomes (3)
Hospital Anxiety and Depression (HAD) score
Measured: 14 days
Percentage of efficient poses of Pain Monitor
Measured: 14 days
Percentage of patient refusal to use of the Pain monitor
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start15 Jun 2017
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Why it stopped: Budgetary and operational issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, PhD, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975778
- Sponsor's protocol ID
- 2016/27
- Other IDs
- 2016-A00709-42
- Acronym
- DOLOAGE
- Status last verified
- Mar 2021
- First submitted
- 24 Nov 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pain During Old People Care Measured by Skin Conductance
- ClinicalTrials.gov ID
- NCT02975778
- Acronym / sponsor ID
- DOLOAGE / 2016/27
- Conditions
- Pain
- Keywords
- 65 years old
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budgetary and operational issues
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aged, 65 and over | Experimental | Device: Pain Monitor™ |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- cutaneous anomaly on the site of measure;
- pacemaker or internal defibrillator;
- extremities twitching;
- Treated by neostigmine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Monitor™Pain measured by Pain Monitor™ | Device | Aged, 65 and over |
Primary outcome
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
3 secondary outcomes
Hospital Anxiety and Depression (HAD) score
Time frame: 14 days
Percentage of efficient poses of Pain Monitor
Time frame: 14 days
Percentage of patient refusal to use of the Pain monitor
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Budgetary and operational issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler, MD, PhD study director
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Monitor™ in people with Pain, run by Hopital Foch at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Budgetary and operational issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.