PainFPS-RCamNCT02571933
Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
An observational study of Pain, run by Cameroon Baptist Convention Health at 1 site in Cameroon.
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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pre-treatment Faces Pain Scale - Revised, Post-treatment Faces Pain Scale - Revised and Cognitive interview
- How many people
- 36 participants
- Where
- 1 siteCameroon
- Study dates
- Oct 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Admitted to Children's Ward
- Complaint of pain
Who cannot join
- Coma
- Traumatic brain injury
- Glasgow Coma Scale (GCS) < 13
- Cognitive delay
- Narcotic/opioid dependency
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Pain
- Being tested
- Pre-treatment Faces Pain Scale - Revised, Post-treatment Faces Pain Scale - Revised, Cognitive interview
- Keywords
- Pediatrics, Pain Scale, Faces Pain Scale - Revised, Cameroon
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment Faces Pain Scale - RevisedOther
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 - RevisedOther
Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.
Cognitive interviewOther
Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Pre-treatment Faces Pain Scale - Revised; Other: Post-treatment Faces Pain Scale - Revised; Other: Cognitive interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cameroon Baptist Convention Health
- Sponsor type
- University, hospital or other
- Collaborators
- Carolinas Medical Center
- Responsible party
- Sponsor
- Investigators
- James R Young, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571933
- Sponsor's protocol ID
- IRB2015-04
- Acronym
- FPS-RCam
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2015
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11427329Huang 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.
PubMed 22512923Jensen 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.
PubMed 3785962Miro 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.
PubMed 15327809Newman 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.
PubMed 15723913Stinson 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.
PubMed 16777328Tomlinson 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.
PubMed 20921070Willis 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.
PubMed 21709820
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
- ClinicalTrials.gov ID
- NCT02571933
- Acronym / sponsor ID
- FPS-RCam / IRB2015-04
- Conditions
- Pain
- Keywords
- Pediatrics, Pain Scale, Faces Pain Scale - Revised, Cameroon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cameroon Baptist Convention HealthUniversity, hospital or other
- Collaborators
- Carolinas Medical Center
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grammar English | – | Other: Pre-treatment Faces Pain Scale - Revised, Other: Post-treatment Faces Pain Scale - Revised, Other: Cognitive interviewPatients 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. |
| Pidgin English | – | Other: Pre-treatment Faces Pain Scale - Revised, Other: Post-treatment Faces Pain Scale - Revised, Other: Cognitive interviewPatients 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. |
| French | – | Other: Pre-treatment Faces Pain Scale - Revised, Other: Post-treatment Faces Pain Scale - Revised, Other: Cognitive interviewPatients 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. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Admitted to Children's Ward
- Complaint of pain
Key exclusion criteria (5 listed)
- Coma
- Traumatic brain injury
- Glasgow Coma Scale (GCS) < 13
- Cognitive delay
- Narcotic/opioid dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-treatment Faces Pain Scale - RevisedPatients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing. | Other | French, Grammar English, Pidgin English |
| Post-treatment Faces Pain Scale - RevisedPatients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain. | Other | French, Grammar English, Pidgin English |
| Cognitive interviewPatients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness. | Other | French, Grammar English, Pidgin English |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- BackgroundBeatty PC, Willis BG, "Research synthesis: the practice of cognitive interviewing. Public Opin Q, 2007, 71:287-311
- BackgroundCartledge 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: PubMed 11427329Hicks 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.
- Background: PubMed 22512923Huang 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.
- Background: PubMed 3785962Jensen 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.
- Background: PubMed 15327809Miro 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.
- Background: PubMed 15723913Newman 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.
- Background: PubMed 16777328Stinson 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.
- Background: PubMed 20921070Tomlinson 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.
- BackgroundWillis GB, Cognitive Interviewing: a tool for improving questionnaire design. Thousand Oaks, Sage Publications, 2005.
- Background: PubMed 21709820Woolley 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Young, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Cameroon Baptist Convention Health at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face validity of pain scale as assessed by cognitive interview probes (time frame: Through study completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571933, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.