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

NCT ID: NCT05307380

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2023-05-15

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.

Conditions

Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with pain

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

"functional pain scale"

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

"functional pain scale"

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital du Valais

OTHER

Sponsor Role: collaborator

Benno Rehberg-Klug

OTHER

Sponsor Role: lead

Responsible Party

Benno Rehberg-Klug

consultant anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Benno Rehberg-Klug, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Hôpital du Valais

Sion, Valais, Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 38870517 (View on PubMed)

Other Identifiers

VALIDE

Identifier Type: -

Identifier Source: org_study_id