Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02571933

Acronym

FPS-RCam

Enrollment

Registered

2015-10-08

Start date

2015-10-31

Completion date

2016-03-31

Last updated

2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pediatrics, Pain Scale, Faces Pain Scale - Revised, Cameroon

Brief summary

This study evaluates the face validity and cultural acceptability of the Faces Pain Scale - Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province, Cameroon. Participants from the four major language/cultural groups evaluated at the hospital with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive interviewing to assess comprehension and clinical accuracy.

Detailed description

Twelve to fifteen pediatric patients complaining of pain from each of the four primary language groups treated at Mbingo Baptist Hospital (Grammar English, Pidgin English, French, and Fulfulde) will be enrolled in the study. Each patient enrolled will trial the Faces Pain Scale - Revised (FPS-R) in his or her native tongue, before receiving standard analgesic treatment as ordered by the provider caring for the patient. One to two hours post analgesia, the patient will be reassessed and the FPS-R will be repeated. After completion of the second FPS-R, an audio-recorded cognitive interview will be performed by trained study personnel. These recordings will be transcribed into English and analyzed on a question-by-question basis to evaluate for themes pertaining to comprehension and understanding, ease of use, and reliability, within the different language groups. Enrollment in the study does not alter the routine pain management offered or received by patients. Rather, the FPS-R will be utilized on patients who are complaining of pain and who will be allocated to receive analgesia regardless of study enrollment.

Interventions

OTHERPre-treatment Faces Pain Scale - Revised

Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.

OTHERPost-treatment Faces Pain Scale - Revised

Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.

OTHERCognitive interview

Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

Healthy volunteers

Yes

Inclusion criteria

* Admitted to Children's Ward * Complaint of pain

Exclusion criteria

* Coma * Traumatic brain injury * Glasgow Coma Scale (GCS) \< 13 * Cognitive delay * Narcotic/opioid dependency

Design outcomes

Primary

Measure	Time frame	Description
Face validity of pain scale as assessed by cognitive interview probes	Through study completion, an average of 3 months	Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R.
Face validity of pain scale as assessed by FPS-R results	Through study completion, an average of 3 months	Detailed review of the FPS-R answers provided by patients in the context of their illness/injury.
Cultural acceptability of pain scale as assessed by cognitive interview probes	Through study completion, an average of 3 months	Question-by-question analysis and review of transcribed cognitive interviews to search for thematic responses that correspond to cultural understanding and ease of use.

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026