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

Cameroon Baptist Convention Health

Status: Completed

Conditions: Pain

Treatments: Other: Cognitive interview; Other: Post-treatment Faces Pain Scale - Revised; Other: Pre-treatment Faces Pain Scale - Revised

Study type: Observational

Funder types: Other

Identifiers

NCT02571933

IRB2015-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

Grammar English

Description:

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.

Treatment:

Other: Cognitive interview

Other: Pre-treatment Faces Pain Scale - Revised

Other: Post-treatment Faces Pain Scale - Revised

Pidgin English

Description:

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.

Treatment:

Other: Cognitive interview

Other: Pre-treatment Faces Pain Scale - Revised

Other: Post-treatment Faces Pain Scale - Revised

French

Description:

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.

Treatment:

Other: Cognitive interview

Other: Pre-treatment Faces Pain Scale - Revised

Other: Post-treatment Faces Pain Scale - Revised