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NCT Number: NCT02571933

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mbingo Baptist Hospital

Mbingo, Northwest Province, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-treatment Faces Pain Scale - Revised

Other

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

Post-treatment Faces Pain Scale - Revised

Other

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

cognitive interview

Other

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

Primary outcomes

  1. Face validity of pain scale as assessed by cognitive interview probes

    Time frame: 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.

  2. Face validity of pain scale as assessed by FPS-R results

    Time frame: 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.

  3. Cultural acceptability of pain scale as assessed by cognitive interview probes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cameroon Baptist Convention Health

Other

Collaborators

  • Carolinas Medical Center

Registry information

Acronym: FPS-RCam

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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