Pain MeasurementNCT04557982
Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale
An observational study of Pain Measurement, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement
- What is being tested?
- A painful procedure (peripheral venepuncture)
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects indicated for peripheral venepuncture (blood draw or peripheral IV cannulation)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Introduction:
For a long time, there has been a myth that children do not remember pain that they were subjected to in the past. However, it has been confirmed that children transfer their negative experience of pain to adulthood. As many studies have shown, information about pain can be obtained from patient self-report, physical response and/or behavioral manifestations. Self-report is considered as the gold standard. The major problem is that most preschool-aged children do not have the necessary cognitive development to use the standard scales.
A group of experts in Canada has developed two new pain scales for this particular age, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS). The S-FPS consists of three faces representing three levels of pain intensity, and the S-COS consists of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks). Their research was based on the assumption that younger children are able to distinguish only two or three levels of pain intensity.
Aim:
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 cognitive ability of the child for the research study will be verified by two control tasks, presented to each child prior to enrolment:
"Describe the presented toy (a star). Choose the biggest star from these three toys (stars) of different sizes."
The tools and procedure:
Children will be asked to evaluate their pain intensity using the S-FPS and the S-COS on three different occasions linked to a painful procedure (before peripheral venepuncture, immediately after the peripheral venepuncture and 5-10 minutes after the peripheral venepuncture).
Before the first venepuncture, the researcher will ask the parents what specific word their child uses to describe pain and then asks the child: "Do you have any pain?," (the child´s word used for pain). If the answer is "no", then the researcher writes "0". If he/she responds "yes", then the child is asked to allocate the perceived pain intensity to the picture, i.e. a corresponding face using the S-FPS, and a corresponding number of blocks, using the S-COS.
The researcher and the attending nurse evaluate the pain at each of these time points using the behavioral scale Face, Legs, Activity, Cry, Consolability (FLACC) (Merkel et al., 2002). The child, the researcher and the attending nurse will do their assessment independently.
Characteristics of the respondents:
The research group will consist of a total of 180 pre-school children (with complete data on all items) who will be subjected to a peripheral venepuncture during their visit to a hospital clinic and who have not received any analgesia prior to the procedure (the researcher will obtain this information during the interview with the parents).
Data Collection:
Before collecting the data, the researcher will individually explain the whole procedure to all participants in such a way that they understand it well, especially to children with regard to their cognitive development. Furthermore, the attending nurse will undergo training concerning data collection and the entire study, as well.
The researcher personally contacts the parents of the child and the child in the waiting room of the Children's Clinic in a tertiary hospital in the city of Olomouc and informs them of the research project. If they agree to being enrolled, the child will be screened for sufficient cognitive development and ability to distinguish three different sizes. This will be done using three identical toys (different sizes) that will be presented to the child and the researcher asks him/her to order the toys from the smallest to the largest. The correct arrangement of toys is the basic criterion for inclusion in the study. The child, the researcher and the attending nurse (the research assistant) participate in the pain assessment. Parents will stay with the child during the whole process, but they do not evaluate the pain. They will be instructed not to provide the child with any verbal or behavioural cues or engage in any behaviour that would either distract the child or that would affect the child´s performance during data collection.
The research study is divided into 3 phases:
Phase 1: before peripheral venepuncture: The researcher and the attending nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Phase 2: immediately after peripheral venepuncture: The researcher and nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Between phase 2 and phase 3, the child is distracted from the procedure. He/she may play with the parent etc.
Phase 3: 5-10 min. after peripheral venepuncture: The researcher and nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Randomization:
Each child evaluates pain using both the S-FPS and S-COS. The order in which these two tools are presented to the child will be random. Randomization will be done for each child three times, before phase 1, phase 2 and phase 3. The order is randomly assigned by a computer program (www.randomizer.org).
- Conditions
- Pain Measurement
- Being tested
- A painful procedure (peripheral venepuncture)
- Keywords
- Pain Measurement, Pain Assessment, Nurse, Nursing, Child, Pediatrics, Instrument, Scale, Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A painful procedure (peripheral venepuncture)Procedure or surgery
The child will undergo a peripheral venepuncture during a scheduled visit to a hospital clinic and routinely provided care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: A painful procedure (peripheral venepuncture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Time 2 (5-10 minutes after the painful procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pardubice
- Responsible party
- Principal investigator, Petra Kasparova, Palacky University
- Investigators
- Petra Kašparová, Mgr., Principal investigator, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557982
- Sponsor's protocol ID
- 123
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28069521Merkel 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.
PubMed 12394307Wild 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.
PubMed 15804318
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale
- ClinicalTrials.gov ID
- NCT04557982
- Acronym / sponsor ID
- 123
- Conditions
- Pain Measurement
- Keywords
- Pain Measurement, Pain Assessment, Nurse, Nursing, Child, Pediatrics, Instrument, Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Collaborators
- University of Pardubice
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
For a long time, there has been a myth that children do not remember pain that they were subjected to in the past. However, it has been confirmed that children transfer their negative experience of pain to adulthood. As many studies have shown, information about pain can be obtained from patient self-report, physical response and/or behavioral manifestations. Self-report is considered as the gold standard. The major problem is that most preschool-aged children do not have the necessary cognitive development to use the standard scales.
A group of experts in Canada has developed two new pain scales for this particular age, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS). The S-FPS consists of three faces representing three levels of pain intensity, and the S-COS consists of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks). Their research was based on the assumption that younger children are able to distinguish only two or three levels of pain intensity.
Aim:
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 cognitive ability of the child for the research study will be verified by two control tasks, presented to each child prior to enrolment:
"Describe the presented toy (a star). Choose the biggest star from these three toys (stars) of different sizes."
The tools and procedure:
Children will be asked to evaluate their pain intensity using the S-FPS and the S-COS on three different occasions linked to a painful procedure (before peripheral venepuncture, immediately after the peripheral venepuncture and 5-10 minutes after the peripheral venepuncture).
Before the first venepuncture, the researcher will ask the parents what specific word their child uses to describe pain and then asks the child: "Do you have any pain?," (the child´s word used for pain). If the answer is "no", then the researcher writes "0". If he/she responds "yes", then the child is asked to allocate the perceived pain intensity to the picture, i.e. a corresponding face using the S-FPS, and a corresponding number of blocks, using the S-COS.
The researcher and the attending nurse evaluate the pain at each of these time points using the behavioral scale Face, Legs, Activity, Cry, Consolability (FLACC) (Merkel et al., 2002). The child, the researcher and the attending nurse will do their assessment independently.
Characteristics of the respondents:
The research group will consist of a total of 180 pre-school children (with complete data on all items) who will be subjected to a peripheral venepuncture during their visit to a hospital clinic and who have not received any analgesia prior to the procedure (the researcher will obtain this information during the interview with the parents).
Data Collection:
Before collecting the data, the researcher will individually explain the whole procedure to all participants in such a way that they understand it well, especially to children with regard to their cognitive development. Furthermore, the attending nurse will undergo training concerning data collection and the entire study, as well.
The researcher personally contacts the parents of the child and the child in the waiting room of the Children's Clinic in a tertiary hospital in the city of Olomouc and informs them of the research project. If they agree to being enrolled, the child will be screened for sufficient cognitive development and ability to distinguish three different sizes. This will be done using three identical toys (different sizes) that will be presented to the child and the researcher asks him/her to order the toys from the smallest to the largest. The correct arrangement of toys is the basic criterion for inclusion in the study. The child, the researcher and the attending nurse (the research assistant) participate in the pain assessment. Parents will stay with the child during the whole process, but they do not evaluate the pain. They will be instructed not to provide the child with any verbal or behavioural cues or engage in any behaviour that would either distract the child or that would affect the child´s performance during data collection.
The research study is divided into 3 phases:
Phase 1: before peripheral venepuncture: The researcher and the attending nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Phase 2: immediately after peripheral venepuncture: The researcher and nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Between phase 2 and phase 3, the child is distracted from the procedure. He/she may play with the parent etc.
Phase 3: 5-10 min. after peripheral venepuncture: The researcher and nurse complete an observational pain report using the FLACC. The child assesses if he/she has pain. If the answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate pain using each self-report tool (S-FPS and S-COS).
Randomization:
Each child evaluates pain using both the S-FPS and S-COS. The order in which these two tools are presented to the child will be random. Randomization will be done for each child three times, before phase 1, phase 2 and phase 3. The order is randomly assigned by a computer program (www.randomizer.org).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children aged 3 < 4 years | – | Procedure: A painful procedure (peripheral venepuncture)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. |
| Children aged 4 < 5 years | – | Procedure: A painful procedure (peripheral venepuncture)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. |
| Children aged 5 < 6 years | – | Procedure: A painful procedure (peripheral venepuncture)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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects indicated for peripheral venepuncture (blood draw or peripheral IV cannulation)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A painful procedure (peripheral venepuncture)The child will undergo a peripheral venepuncture during a scheduled visit to a hospital clinic and routinely provided care. | Procedure or surgery | Children aged 3 < 4 years, Children aged 4 < 5 years, Children aged 5 < 6 years |
Primary outcome
Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Faces Pain Scale (using self-report).
Time frame: Time 0 (immediately prior to the painful procedure)
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.
Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
Time frame: Time 0 (immediately prior to the painful procedure)
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).
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).
Time frame: Time 0 (immediately prior to the painful procedure)
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.
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).
Time frame: Time 0 (immediately prior to the painful procedure)
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.
Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Faces Pain Scale (using self-report).
Time frame: Time 1 (immediately after the painful procedure)
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.
Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
Time frame: Time 1 (immediately after the painful procedure)
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).
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).
Time frame: Time 1 (immediately after the painful procedure)
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.
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).
Time frame: Time 1 (immediately after the painful procedure)
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.
Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Faces Pain Scale (using self-report).
Time frame: Time 2 (immediately after the painful procedure)
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.
Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
Time frame: Time 2 (5-10 minutes after the painful procedure)
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).
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).
Time frame: Time 2 (5-10 minutes after the painful procedure)
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.
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).
Time frame: Time 2 (5-10 minutes after the painful procedure)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 28069521Emmott 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.
- Background: PubMed 12394307Merkel 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.
- Background: PubMed 15804318Wild 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.
- Research RandomizerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Kašparová, Mgr. principal investigator
Palacky University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Faces Pain Scale (using self-report). (time frame: Time 0 (immediately prior to the painful procedure)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557982, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.