Clinical trial NCT02571933: Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
Official title: Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pediatrics
Pain Scale
Faces Pain Scale - Revised
Cameroon
Lead sponsor: Cameroon Baptist Convention Health
Sponsor class: OTHER
Collaborators: name: Carolinas Medical Center
First posted: 2015-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population encompasses the four primary language-defined cultural groups that present to Mbingo Baptist Hospital. Goal of 12-15 pediatric patients per cohort (Grammar English, Pidgin English, French, and Fulfulde speaking), who have pain as part of their presenting complaint.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Face validity of pain scale as assessed by cognitive interview probes
timeFrame: Through study completion, an average of 3 months
measure: Face validity of pain scale as assessed by FPS-R results
timeFrame: Through study completion, an average of 3 months
measure: Cultural acceptability of pain scale as assessed by cognitive interview probes
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mbingo
country: Cameroon
facility: Mbingo Baptist Hospital
state: Northwest Province
Study officials:
affiliation: Carolinas Medical Center
name: James R Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
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