NCT05307380

Brief Summary

The project will validate the French translation of the "Defense and Veterans Pain Rating Scale (DVPRS)" in multiple patient types: postoperative patients, non-surgical patients with chronic pain in the context of geriatrics, palliative care, and rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

March 4, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

March 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

March 4, 2022

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • construct validity for acute pain

    association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale.

    immediate after inclusion

Secondary Outcomes (5)

  • construct validity for chronic pain

    immediate after inclusion

  • Criterion validity: ability to be mobilized

    immediate after inclusion

  • Criterion validity : pain intensity considered as tolerable

    immediate after inclusion

  • Sensitivity to change

    immediate after inclusion

  • Patient and caregiver evaluation of ease of use

    immediate after inclusion

Study Arms (1)

patients with pain

patients with acute postoperative or post-traumatic pain or chronic pain

Diagnostic Test: "functional pain scale"

Interventions

French translation of the Defence and Veterans Pain Rating Scale (DVPRS)

patients with pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* 100 postoperative patients, * 50 ambulatory chronic pain patients * 50 hospitalized patients with non-surgical pain (medical, oncological, rehabilitative, geriatric, palliative), In addition, the following subgroups are planned within the total of 200 patients: * 30 postoperative patients with a pain intensity of at least 4 will receive the functional pain scale twice, before and after an analgesic on-demand treatment. * 30 patients will receive a separate sheet on which they are asked to connect the numeric pain intensity values (0-10) to the word descriptors of the functional pain scale. * 30 patients \>75 years old

You may qualify if:

  • Patients with acute or chronic pain, either having undergone painful surgical procedures, or having a chronic pain consultation, or being hospitalized in oncology, rehabilitative, geriatric or palliative care with painful conditions
  • French-speaking and able to understand the study information
  • ≥18 years of age

You may not qualify if:

  • Inability to understand the consent form and the questionnaire, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital du Valais

Sion, Valais, 1951, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Related Publications (1)

  • Safran SL, Follonier D, Weber E, Vayne-Bossert P, Ahrendts U, Rehberg-Klug B. Cross-cultural adaptation and psychometric validation of the French version of the Defense and Veterans Pain Rating Scale for acute and chronic pain: a prospective clinical study. Pain Med. 2024 Oct 1;25(10):630-636. doi: 10.1093/pm/pnae049.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benno Rehberg-Klug, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
consultant anesthesiologist

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 1, 2022

Study Start

March 20, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations