PainNOUNOURSNCT02252003
Development and Validation of a New Pain Scale for Children
A study testing Pain scales testing in people with Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pain scales testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2015to Jul 2017
- Phase
- Interventional
- 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 2 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Affiliated with the French healthcare system
- Agreed to participate in the study, of which parents/ holders of parental authority signed the informed consent form
- Scale development phase:
- Children aged from 4 to 11 years at inclusion
- Having already experienced pain
- Scale validation phase:
Show all 9Show fewer
- Children aged from 2 to 11 years old at inclusion
- Hospitalized in one of the Hôpital Femme-Mère-Enfant (HFME) departments
- At risk of presenting pain, that is to whom the pain is usually evaluated in a systematic way
Who cannot join
- Children among whom the understanding and/or the language is not sufficient to allow a good comprehension of study instructions
- Children participating simultaneously in another interventional research, being able to interfere with the study results
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant
Bron, 69677
About this study
Official title: Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)
In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks.
For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations.
Read more
We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children.
The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children.
The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents.
Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R.
Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.
- Conditions
- Pain
- Being tested
- Pain scales testing
- Keywords
- Children, Pain, Pain scale evaluation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain scales testingOther
| Study group | Role | What they receive |
|---|---|---|
| Pain scales testing | Experimental | Not described Receives: Other: Pain scales testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment (4-11 years old)
Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated.
Measured: Baseline
Secondary outcomes (4)
Pain assessment (4-11 years old) depending on age.
Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of discriminating characteristics of each scale (teddy scale, FPS-R and VAS), according to the age (continuing age, or in range: 4-6, 6-8 and 8-11) will be performed.
Measured: Baseline
Scale preference (4-11 years old)
The 174 patients (aged 4-11 years old) will be asked to choose the scale they preferred between teddy scale, VAS and FPS-R. The number of times where the teddy scale is preferred will be counted (result expressed in percentage) and compared to the 2 other scales.
Measured: Baseline
Sensibility of change of teddy and FPS-R scales
The sensibility of change (before/after treatment intake) will be measured by the size-effect (mean of the differences divided by the standard deviation before treatment) and by standardized mean responses (mean of the differences divided by the differences standard deviations).
Measured: Baseline
Pain assessment (2-3 years-old)
Children aged 2-3 years old will be asked to score the pain they feel at that time, using the teddy scale while parents will fill up the FLACC scale. The measure of the correlation between scores of the 2 pain scales: teddy scale score (0,2,4,6,8,10) and FLACC score (continuing from 0 to 10), will be performed using statistical models.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start21 May 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole VUILLEROT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252003
- Sponsor's protocol ID
- 2013.811
- Other IDs
- 2013-A00849-36
- Acronym
- NOUNOURS
- Status last verified
- Feb 2018
- First submitted
- 3 Sep 2014
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)
- ClinicalTrials.gov ID
- NCT02252003
- Acronym / sponsor ID
- NOUNOURS / 2013.811
- Conditions
- Pain
- Keywords
- Children, Pain, Pain scale evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Sep 2014 (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.
In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks.
For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations.
We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children.
The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children.
The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents.
Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R.
Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain scales testing | Experimental | Other: Pain scales testing |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Affiliated with the French healthcare system
- Agreed to participate in the study, of which parents/ holders of parental authority signed the informed consent form
- Children aged from 4 to 11 years at inclusion
- Having already experienced pain
- Children aged from 2 to 11 years old at inclusion
Key exclusion criteria (2 listed)
- Children among whom the understanding and/or the language is not sufficient to allow a good comprehension of study instructions
- Children participating simultaneously in another interventional research, being able to interfere with the study results
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 |
|---|---|---|
| Pain scales testing | Other | Pain scales testing |
Primary outcome
Pain assessment (4-11 years old)
Time frame: Baseline
Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated.
4 secondary outcomes
Pain assessment (4-11 years old) depending on age.
Time frame: Baseline
Scale preference (4-11 years old)
Time frame: Baseline
Sensibility of change of teddy and FPS-R scales
Time frame: Baseline
Pain assessment (2-3 years-old)
Time frame: Baseline
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 14 Feb 2018.
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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.
Carole VUILLEROT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain scales testing in people with Pain, run by Hospices Civils de Lyon at 1 site in France.
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 9 inclusion and 2 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 14 Feb 2018. 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 France. 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?
Pain assessment (4-11 years old) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2018.