Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
NCT ID: NCT02571933
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2015-10-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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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.
Pre-treatment Faces Pain Scale - Revised
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
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
Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
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.
Pre-treatment Faces Pain Scale - Revised
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
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
Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
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.
Pre-treatment Faces Pain Scale - Revised
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
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
Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
Interventions
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Pre-treatment Faces Pain Scale - Revised
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
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
Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
Eligibility Criteria
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Inclusion Criteria
* Complaint of pain
Exclusion Criteria
* Traumatic brain injury
* Glasgow Coma Scale (GCS) \< 13
* Cognitive delay
* Narcotic/opioid dependency
4 Years
16 Years
ALL
Yes
Sponsors
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Carolinas Medical Center
OTHER
Cameroon Baptist Convention Health
OTHER
Responsible Party
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Principal Investigators
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James R Young, MD
Role: PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Locations
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Mbingo Baptist Hospital
Mbingo, Northwest Province, Cameroon
Countries
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References
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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):173-183. doi: 10.1016/S0304-3959(01)00314-1.
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.
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.
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.
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.
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.
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.
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. doi: 10.1177/1049731503257882.
Other Identifiers
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IRB2015-04
Identifier Type: -
Identifier Source: org_study_id