Development and Validation of a New Pain Scale for Children

NCT ID: NCT02252003

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-21
• Study Completion Date: 2017-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pain scales testing

Group Type: EXPERIMENTAL

Pain scales testing

Intervention Type: OTHER

Interventions

Pain scales testing

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole VUILLEROT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant

Bron, , France

Countries

France

Other Identifiers

2013-A00849-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013.811

Identifier Type: -

Identifier Source: org_study_id