Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04557982
Study type Observational
Source Palacky University
Contact
Status Completed
Phase
Start date September 1, 2020
Completion date October 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT02763059 - Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement Phase 4
Completed NCT00524927 - Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain Phase 4
Completed NCT04124289 - A Functional Pain Scale to Improve the Patient Experience
Completed NCT03675945 - Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children
Completed NCT04451252 - Predicting Response to Interventional Pain Management Techniques in Chronic Low Back Pain in a Prospective Cohort.
Completed NCT03727373 - Qualitative Study for Pain Measurement Using Innovative Health Technology
Not yet recruiting NCT04555928 - Measuring Pain Intensity in Older Patients: A Comparison of Five Scales
Completed NCT06201195 - Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia N/A
Completed NCT02603783 - Esophageal capsaïcin Infusion and Mucosal Integrity N/A
Completed NCT04050384 - Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates N/A
Recruiting NCT05129007 - Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
Completed NCT05881551 - Pain Assessment Via Force Measurement Using eEgg After Blockade of the Lumbar Facet Joints N/A
Completed NCT04888026 - Impact on Pain Sensitivity of Clinical Interaction N/A
Recruiting NCT05223790 - Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
Terminated NCT02630134 - Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring N/A
Completed NCT05822336 - Duration of IM Injection and Pain Intensity N/A
Completed NCT02919891 - Relationship of Intra-Epidermal Nerve Fibre Density (IENFD) and Structure to Chronic Post-Mastectomy Pain Syndrome (PMPS)
Completed NCT04392180 - COA-APTIC Caregiver Concept Elicitation Study
Not yet recruiting NCT06431802 - Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children N/A
Completed NCT01211600 - Cesarean Trial of Staples vs. Sutures N/A