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

Pain Clinical Trial

— FPS-RCam  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571933
• Other study ID #: IRB2015-04
• Status: Completed
• Phase: N/A
• First received: September 29, 2015
• Last updated: December 22, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Cameroon	Mbingo Baptist Hospital	Mbingo	Northwest Province

Sponsors (2)

Lead Sponsor	Collaborator
Cameroon Baptist Convention Health	Carolinas Medical Center

Country where clinical trial is conducted

Cameroon, 

References & Publications (11)

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

Outcome

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