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Clinical Trials/NCT05307380
NCT05307380
Completed
N/A

Transcultural Validation of the French Version of the Functional Pain Scale "Defense and Veterans Pain Rating Scale DVPRS"

Benno Rehberg-Klug2 sites in 1 country232 target enrollmentMarch 20, 2022
ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Benno Rehberg-Klug
Enrollment
232
Locations
2
Primary Endpoint
construct validity for acute pain
Status
Completed
Last Updated
2 years ago

Overview

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

Detailed Description

The primary objective of this study is to validate the French translation of the multidimensional "Defence and Veterans Pain Rating Scale" (= functional pain scale). The hypothesis is that the functional pain scale is a valid measurement instrument for acute and chronic pain evaluation in a wide range of patient groups: postoperative patients, hospitalized patients with non-surgical pain (medical, oncological, rehabilitative, geriatric, palliative), and ambulatory chronic pain patients. The primary endpoint is construct validity assessed as the association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale. In addition to the association with the NRS, construct validity will be assessed by correlation of pain intensity noted on the functional pain scale intensity with the pain intensity score of the BPI for chronic pain patients, and the item "severe pain time" of the International Pain Outcomes Questionnaire (8) for postoperative patients. Content validity will be assessed in a subgroup of patient by the association of the values for pain intensity (0-10) on the functional pain scale and the corresponding word descriptors. A factor analysis of all items of the functional pain scale will be performed. Internal consistency of the functional pain scale will be tested by calculating Cronbach's alpha across all items. Criterion validity will be assessed in patients for whom mobilisation is an important therapeutic goal as the discrimation between patients who can be mobilized and those who can't because of pain, and patients who consider their pain as tolerable and those who do not. This discrimative ability will also be compared to the classical numeric rating scale, as it is a potential advantage of the functional pain scale. For the numeric rating scale, a large overlap in pain intensity for patients who consider their pain as tolerable and those who do not has been found(9). Sensitivity to change will be evaluated by comparing values before and after an analgesic treatment for a subgroup of patients with an initial pain intensity of at least 4/10 on the functional pain scale. However, since patients with high pain levels will not be able to fill in the questionnaire, this is only an exploratory endpoint of this study. Patient and caregiver evaluation of ease of use will also be evaluated, as well as patient judgement of tolerable pain levels.

Registry
clinicaltrials.gov
Start Date
March 20, 2022
End Date
May 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Benno Rehberg-Klug
Responsible Party
Sponsor Investigator
Principal Investigator

Benno Rehberg-Klug

consultant anesthesiologist

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

construct validity for acute pain

Time Frame: immediate after inclusion

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

Secondary Outcomes

  • Criterion validity : pain intensity considered as tolerable(immediate after inclusion)
  • Criterion validity: ability to be mobilized(immediate after inclusion)
  • construct validity for chronic pain(immediate after inclusion)
  • Sensitivity to change(immediate after inclusion)
  • Patient and caregiver evaluation of ease of use(immediate after inclusion)

Study Sites (2)

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