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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Pre-treatment Faces Pain Scale - Revised
* Other: Post-treatment Faces Pain Scale - Revised
* Other: Cognitive interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Grammar English<br>Patients who primarily speak Grammar English. Patients will answer the FPS-R in Grammar English both before and after administration of routine analgesia for pain (analgesia to be administered regardless of enrollment in study). Study participants will answer a series of questions - the cognitive interview - after second FPS-R to assess for ease of use and how well it is understood. | Other: Pre-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.<br>Other: Post-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.<br>Other: Cognitive interview<br>* Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.<br>|
| Pidgin English<br>Patients who primarily speak Pidgin English. Patients will answer the FPS-R in Pidgin English both before and after administration of routine analgesia for pain (analgesia to be administered regardless of enrollment in study). Study participants will answer a series of questions - the cognitive interview - after second FPS-R to assess for ease of use and how well it is understood. | Other: Pre-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.<br>Other: Post-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.<br>Other: Cognitive interview<br>* Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.<br>|
| French<br>Patients who primarily speak French. Patients will answer the FPS-R in French both before and after administration of routine analgesia for pain (analgesia to be administered regardless of enrollment in study). Study participants will answer a series of questions - the cognitive interview - after second FPS-R to assess for ease of use and how well it is understood. | Other: Pre-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.<br>Other: Post-treatment Faces Pain Scale - Revised<br>* Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.<br>Other: Cognitive interview<br>* Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Pain Scale, Faces Pain Scale - Revised, Cameroon