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

NCT04557982 | Completed

• 1 other identifier: 123
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain Measurement; Pain Assessment; Nurse; Nursing; Child; Pediatrics; Instrument; Scale; Tool

Outcome Measures

Primary Outcomes (12)

• Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Faces Pain Scale (using self-report).

  The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.

  Time 0 (immediately prior to the painful procedure)

• Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).

  The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).

  Time 0 (immediately prior to the painful procedure)

• Pain intensity at Time 0 (immediately prior to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.

  Time 0 (immediately prior to the painful procedure)

• Pain intensity at Time 0 (immediately prior to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.

  Time 0 (immediately prior to the painful procedure)

• Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Faces Pain Scale (using self-report).

  The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.

  Time 1 (immediately after the painful procedure)

• Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).

  The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).

  Time 1 (immediately after the painful procedure)

• Pain intensity at Time 1 (immediately after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.

  Time 1 (immediately after the painful procedure)

• Pain intensity at Time 1 (immediately after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.

  Time 1 (immediately after the painful procedure)

• Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Faces Pain Scale (using self-report).

  The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.

  Time 2 (immediately after the painful procedure)

• Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).

  The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).

  Time 2 (5-10 minutes after the painful procedure)

• Pain intensity at Time 2 (5-10 minutes after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 0 representing no pain.

  Time 2 (5-10 minutes after the painful procedure)

• Pain intensity at Time 2 (5-10 minutes after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).

  The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 0 representing no pain.

  Time 2 (5-10 minutes after the painful procedure)

Study Arms (3)

Children aged 3 < 4 years

Children aged 3 \< 4 years will be recruited using convenience sampling and meeting the inclusion criteria (child Czech-speaking, able to distinguish between small/medium sized/large toy, willing to cooperate, parent/significant other is present and signs informed consent). The child will be explained the use of the S-COS, and S-FPS and self-reports pain intensity immediately prior to the procedure (Time 0), immediately after the procedure (Time 1) and after 5-10 minutes (Time 2). Furthermore, at Time 0, 1 and 2, the child´s pain level is independently assessed by the attending nurse and by the researcher.

Procedure: A painful procedure (peripheral venepuncture)

Children aged 4 < 5 years

Children aged 4 \< 5 years will be recruited using convenience sampling and meeting the inclusion criteria (child Czech-speaking, able to distinguish between small/medium sized/large toy, willing to cooperate, parent/significant other is present and signs informed consent). The child will be explained the use of the S-COS, and S-FPS and self-reports pain intensity immediately prior to the procedure (Time 0), immediately after the procedure (Time 1) and after 5-10 minutes (Time 2). Furthermore, at Time 0, 1 and 2, the child´s pain level is independently assessed by the attending nurse and by the researcher.

Procedure: A painful procedure (peripheral venepuncture)

Children aged 5 < 6 years

Children aged 5 \< 6 years will be recruited using convenience sampling and meeting the inclusion criteria (child Czech-speaking, able to distinguish between small/medium sized/large toy, willing to cooperate, parent/significant other is present and signs informed consent). The child will be explained the use of the S-COS, and S-FPS and self-reports pain intensity immediately prior to the procedure (Time 0), immediately after the procedure (Time 1) and after 5-10 minutes (Time 2). Furthermore, at Time 0, 1 and 2, the child´s pain level is independently assessed by the attending nurse and by the researcher.

Procedure: A painful procedure (peripheral venepuncture)

Interventions

A painful procedure (peripheral venepuncture) PROCEDURE

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

Children aged 3 < 4 years; Children aged 4 < 5 years; Children aged 5 < 6 years

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects indicated for peripheral venepuncture (blood draw or peripheral IV cannulation)

You may qualify if:

• Czech-speaking
• male or female
• aged 3-6 years
• scheduled to undergo peripheral venepuncture
• ability to distinguish three sizes using a toy: small/medium sized/large
• signed informed consent by parent/significant other

You may not qualify if:

• non-Czech speaking
• refusal to cooperate by the child,
• low cognitive ability (inability to distinguish three sizes using a toy: small/medium sized/large)
• refusal to cooperate by the parent/significant other

Sponsors & Collaborators

• Palacky University: lead
• University of Pardubice: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

Related Publications (3)

• Emmott AS, West N, Zhou G, Dunsmuir D, Montgomery CJ, Lauder GR, von Baeyer CL. Validity of Simplified Versus Standard Self-Report Measures of Pain Intensity in Preschool-Aged Children Undergoing Venipuncture. J Pain. 2017 May;18(5):564-573. doi: 10.1016/j.jpain.2016.12.015. Epub 2017 Jan 6.

  PMID: 28069521 BACKGROUND

• Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8. doi: 10.1097/00000446-200210000-00024. No abstract available.

  PMID: 12394307 BACKGROUND

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

Related Links

• Research Randomizer

Study Officials

• Petra Kašparová, Mgr.

  Palacky University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 22, 2020
• Study Start: September 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)