跳至主要内容
临床试验/NCT05322018
NCT05322018招募中不适用

Validation of a Novel Digital Pain Measure, Faces Thermometer Scale (FTS) in a Swedish Dental Context

Malmö University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Faces Thermometer Scale

研究概览

简要总结

The aim of this study is to evaluate validity and reliability of a novel digital pain measure tool, the Faces Thermometer Scale (FTS). Pain is commonly reported by children and adolescents undergoing dental treatment. Pain is also a strongly contributing factor in the development of Dental Fear and Anxiety (DFA). Professionals often underestimate the pain perceived by their patients. Self-report tools are seldom used to measure pain in a clinical setting, denying child patients the possibility to communicate their pain experiences.

The aim of this study is to evaluate validity and reliability of a digital self-report pain measure tool, the Faces Thermometer Scale (FTS). Children and adolescents (N=150) aged 8 to 17 years visiting a dental clinic will be asked to score their pain using three different self-report pain tools; FTS, Faces Pain Scale-Revised (FPS-R) and Color Analog Scale (CAS). The validity and reliability of FPS-R and CAS is long established and will therefore be used to evaluate the psychometric properties of FTS.

详细描述

BACKGROUND Pain is a personal experience influenced by biological, psychological, and social factors. Pain is more than the sum of activity in sensory neurons and therefore different from nociception (Raja et al., 2020). Pain due to dental treatments and procedures is commonly reported by children and adolescents (Ghanei et al., 2018). Dental treatments giving rise to pain is considered a strongly contributing factor in the development of Dental Fear and Anxiety (DFA) and Dental Behavioral Management Problems (DBMP) in children (Klingberg et al., 1994; Radaal et al., 2002). Several studies have pointed to professionals underestimating pain compared to the perceived pain as reported by children themselves (Beyer et al., 1990; Versloot et al., 2004). Self-report tools are seldom used to measure pain in the clinical setting, denying child patients the possibility to communicate their pain experiences. One study showed that validated pain measure tools were used in only 19 % of cases in post-anesthesia care (Hetland Smeland et al., 2018). These findings point to the importance of letting children report their own pain experiences using validated tools easily accessible and which also children are willing to use.

As every-day life becomes progressively more digital through the use of internet and mobile devices the need for a valid and reliable digital self-report pain measure has become apparent. The use of a digital tool would also provide possibilities for real-time pain measure and empower children and adolescents in making their pain heard and understood facilitating pain-management in the inpatient care as well as outside the clinical setting. Analog scales and tools previously used for measuring pain are not directly transferable to a digital format. Digital tools are also preferred by children themselves over paper versions of the same scale. (Wood et al., 2011) The Faces Thermometer Scale (FTS) is a newly devised digital self-report tool to assess the intensity of children's and adolescents' pain. The FTS uses a 0 to 10 metric, 0 representing no pain and 10 indicating much pain. Each individual metric on the numeric scale is associated with a face and a color. FTS is part of and available through the mobile application Pictorial Support in Person-Centred Care for Children (PicPecc), which can be downloaded from App Store or Google Play.

Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001) and Color Analog Scale (CAS) (McGrath et al., 1996) are two frequently used and established analog self-report tools used in different settings to measure pain in children and adolescents. FPS-R and CAS have previously demonstrated convergent and discriminative validity, except for children under 7 years of age (Tsze et al., 2013). The same study showed good responsivity and reliability for both tools. FPS-R and CAS will be used to evaluate the psychometric properties of FTS.

The aim of this study is to evaluate the validity and reliability of the newly developed digital FTS tool for measuring children's pain. The hypotheses for this study are:

The FTS demonstrate an acceptable convergent validity in measuring pain in children aged 8-17, in relation to FPS-R and CAS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8 to 17 years of age, undergoing dental procedures and/or examinations

排除标准

  • cannot understand Swedish nor instructions on how to use the pain measure tools

结局指标

主要结局

Faces Thermometer Scale

时间窗: Change in pain at up to 4 hours

The Faces Thermometer Scale is a digital pain measure tool, which allows individuals to rate pain on a scale from 0 to 10 at intervals of 1. A higher reading indicates higher pain intensity.

次要结局

  • Faces Pain Scale-Revised(Change in pain at up to 4 hours)
  • Color Analog Scale(Change in pain at up to 4 hours)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rikard Roxner

Principal Investigator

Malmö University

研究点 (1)

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