Pain Clinical Trial
— FPS-RCamOfficial title:
Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
Verified date | December 2016 |
Source | Cameroon Baptist Convention Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Cameroon: Mbingo Baptist Hospital |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 16 Years |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Cameroon | Mbingo Baptist Hospital | Mbingo | Northwest Province |
Lead Sponsor | Collaborator |
---|---|
Cameroon Baptist Convention Health | Carolinas Medical Center |
Cameroon,
Beatty PC, Willis BG, "Research synthesis: the practice of cognitive interviewing. Public Opin Q, 2007, 71:287-311
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
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):173-83. — View Citation
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. — View Citation
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-26. — View Citation
Miró 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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Willis GB, Cognitive Interviewing: a tool for improving questionnaire design. Thousand Oaks, Sage Publications, 2005.
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
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