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Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale

NCT04557982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2024-02-13

No results posted yet for this study

Summary

The aim is to create a Czech version of pain assessment tools in children, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS), including methodology for their use in practice, and to establish their validity and reliability in pre-school children. The S-FPS is composed of three faces representing three different levels of pain, and the S-COS shows three blocks that symbolize three levels of intensity of pain. The instrument translation and linguistic validation process will be based on the International Society for Pharmacoeconomics and Outcomes Research guidelines (Wild et al., 2005). Validity and reliability will be tested by comparing the children´s pain intensity using the S-FPS and S-COS, which will be completed by the children, and the instrument Face, Legs, Activity, Cry, Consolability (FLACC), which will be completed independently by the attending nurse and the researcher. A repeated measures design will be used as all assessments will be performed prior to a painful procedure (peripheral venepuncture) and will be repeated twice after the painful procedure, once immediately after the painful procedure and a second time 5-10 minutes after the painful procedure. A total of 180 children with will be recruited (aged 3-6 years) from whom complete data will be obtained.

Conditions

  • Pain Measurement

Interventions

PROCEDURE

A painful procedure (peripheral venepuncture)

The child will undergo a peripheral venepuncture during a scheduled visit to a hospital clinic and routinely provided care.

Sponsors & Collaborators

  • University of Pardubice

    collaborator OTHER

  • Palacky University

    lead OTHER

Principal Investigators

  • Petra Kašparová, Mgr. · Palacky University

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557982 on ClinicalTrials.gov