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

NCT02571933 | Completed

• 1 other identifier: IRB2015-04
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pediatrics; Pain Scale; Faces Pain Scale - Revised; Cameroon

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Grammar English

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

Pidgin English

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

French

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

Interventions

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.

French; Grammar English; Pidgin English

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.

French; Grammar English; Pidgin English

Cognitive interview OTHER

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

French; Grammar English; Pidgin English

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Admitted to Children's Ward
• Complaint of pain

You may not qualify if:

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

Sponsors & Collaborators

• Cameroon Baptist Convention Health: lead
• Carolinas Medical Center: collaborator

Study Sites (1)

Mbingo Baptist Hospital

Mbingo, Northwest Province, Cameroon

Location

Related Publications (11)

• Beatty PC, Willis BG, "Research synthesis: the practice of cognitive interviewing. Public Opin Q, 2007, 71:287-311

  BACKGROUND

• Cartledge P, et al, "A pilot acceptability study of the Paediatric Faces Pain Scale among adults attending a sub-Saharan hospice. PCAU J Palliat Care 2005, 7:14-18

  BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• Huang KT, Owino C, Vreeman RC, Hagembe M, Njuguna F, Strother RM, Gramelspacher GP. Assessment of the face validity of two pain scales in Kenya: a validation study using cognitive interviewing. BMC Palliat Care. 2012 Jul 10;11:5. doi: 10.1186/1472-684X-11-5.

  PMID: 22512923 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Miro J, Huguet A. Evaluation of reliability, validity, and preference for a pediatric pain intensity scale: the Catalan version of the faces pain scale--revised. Pain. 2004 Sep;111(1-2):59-64. doi: 10.1016/j.pain.2004.05.023.

  PMID: 15327809 BACKGROUND

• Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. doi: 10.1136/adc.2003.044404.

  PMID: 15723913 BACKGROUND

• Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.

  PMID: 16777328 BACKGROUND

• Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

  PMID: 20921070 BACKGROUND

• Willis GB, Cognitive Interviewing: a tool for improving questionnaire design. Thousand Oaks, Sage Publications, 2005.

  BACKGROUND

• Woolley ME, Bowen GL, Bowen NK. Cognitive Pretesting and the Developmental Validity of Child Self-Report Instruments: Theory and Applications. Res Soc Work Pract. 2004 May;14(3):191-200. doi: 10.1177/1049731503257882.

  PMID: 21709820 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• James R Young, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

CA (1)