Clinical trial NCT02252003: Development and Validation of a New Pain Scale for Children
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Children
Pain
Pain scale evaluation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain assessment (4-11 years old)
timeFrame: Baseline
Secondary outcomes:
measure: Pain assessment (4-11 years old) depending on age.
timeFrame: Baseline
measure: Scale preference (4-11 years old)
timeFrame: Baseline
measure: Sensibility of change of teddy and FPS-R scales
timeFrame: Baseline
measure: Pain assessment (2-3 years-old)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Carole VUILLEROT, MD
role: PRINCIPAL_INVESTIGATOR
References: