Development and Validation of a New Pain Scale for Children

NCT02252003 | Completed

• 2 other identifiers: 2013.8112013-A00849-36
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Children; Pain; Pain scale evaluation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (4)

• Pain assessment (4-11 years old) depending on age.

  Baseline

• Scale preference (4-11 years old)

  Baseline

• Sensibility of change of teddy and FPS-R scales

  Baseline

• Pain assessment (2-3 years-old)

  Baseline

Study Arms (1)

Pain scales testing

EXPERIMENTAL

Other: Pain scales testing

Interventions

Pain scales testing OTHER

Pain scales testing

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Having already experienced pain
• Scale validation phase:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carole VUILLEROT, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 29, 2014
• Study Start: May 21, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

FR (1)