Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales

NCT ID: NCT02174744

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The pain of the elderly is often trivialized and ignored in spite of its high frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.

The evaluation of pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than to the real age. For that purpose, the investigators have self-assessment scales as the Numeric Pain Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a bias because, some patients do not express spontaneously their pain.

So behavioural scales were elaborated to solve the difficulties of detection and to care the pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be completed) whose objective is the observation of behavioural changes caused by the acute pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in few minutes a good evaluation of pain) whose objective is the observation of behavioural changes caused by the chronic pain in elderly having communication impairments.

In practice, because of its popularity, the Algoplus® scale is widely used out of the specificity in which it has been validated. Practitioners, worried about this misuse, suggested to Doloplus® group, to test the concordance between the two behavioural scales in order to develop recommendations more targeted. The risk is that the use of the Algoplus® scale may underestimate pain that would have been detected by Doloplus® scale, and lead to under-treatment or non-treatment of pain in elderly having communication disorders.

This study aims to establish the concordance between these two scales to generate advices and recommendations to assess efficiently the pain in this vulnerable population.

The main objective of this study is to assess whether the use of Algoplus® scale is in good concordance with Doloplus® scale.

The secondary objective of this study is to assess the concordance with different levels of Algoplus® pain scale: (0-1), (2-3), (4-5).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The physician investigator will identify and include patients in the study according to the inclusion criteria. Management of patients do not differ from the usual care in the service concerned. During the usual patient care, several pain assessments will be performed: Numeric Pain Rating Scale, MMSE score if the patient is able to communicate, Algoplus® scale and Doloplus® scale will be performed by doctors and/or caregivers without patient's participation. The patient will be assessed by two doctors and or caregivers (the time interval between the two assessments must be as short as possible).

In a first step, 48 hours after patient admission in the care service, a first doctor/caregiver will assess pain with Numeric Pain Rating Scale and evaluate MMSE score if it is possible and then assess pain with the Algoplus® scale. The results of the Numeric Pain Rating Scale, the Algoplus® scale and the MMSE score will be recorded in the medical record and in the study Case Report Form.

In a second step, less than 3 hours after the first assessment, a second doctor/caregiver will assess pain with the Doloplus® scale and the result will be recorded in the medical record and in the study Case Report Form.

The Case Report Form (containing demographic data, the history of pain, analgesics treatment, scores of Numeric Pain Rating Scale, MMSE, Algoplus® scale and Doloplus® scale) will be faxed to the Coordinating Center at Clermont-Ferrand in the day.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain in Elderly Patients Having Communication Disorders.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

numerical scale

numeric pain rating scale

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

numeric pain rating scale

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of 65 or more years old
* Patients having communication disorders
* Hospitalization for at least 48 hours

Exclusion Criteria

* Patients of less than 65 years
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center

UNKNOWN

Sponsor Role collaborator

Ms Joëlle DEVOT - Collaborator

UNKNOWN

Sponsor Role collaborator

Dr Patrice RAT - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Chandra COLOM - Investigator

UNKNOWN

Sponsor Role collaborator

Mr Dieudonné ENDOUGOU - Collaborator

UNKNOWN

Sponsor Role collaborator

Dr Cyril GUILLAUME - Investigator

UNKNOWN

Sponsor Role collaborator

Ms Nathalie ROUX - Collaborator

UNKNOWN

Sponsor Role collaborator

Dr Yves PASSADORI - Investigator

UNKNOWN

Sponsor Role collaborator

Ms Nathalie DANNENBERGER - Collaborator

UNKNOWN

Sponsor Role collaborator

Dr Micheline MICHEL - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Sylvie CHAPIRO- Investigator

UNKNOWN

Sponsor Role collaborator

Dr Jean-François VILLARD - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Bernard WARY- Investigator

UNKNOWN

Sponsor Role collaborator

Dr Anne-Cécile BOURJAL - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Catherine BLUNTZ - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Françoise CAPRIZ - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Marie FLOCCIA - Investigator

UNKNOWN

Sponsor Role collaborator

Dr Jérôme BOHATIER - Investigator

UNKNOWN

Sponsor Role collaborator

Ms Linh NGUYEN PHUONG - Collaborator

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gisèle PICKERING

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHU-0190

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3h of PNE on BDNF and Pain Levels
NCT05736172 RECRUITING NA