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心率监测在非言语患者中急性疼痛的检测:一项随机对照临床试验研究方案。

Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial.

机构信息

K.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway.

Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.

出版信息

BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1.

DOI:10.1186/s12888-023-04757-1
PMID:37060049
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10103503/
Abstract

BACKGROUND

Autism entails reduced communicative abilities. Approximately 30% of individuals with autism have intellectual disability (ID). Some people with autism and ID are virtually non-communicative and unable to notify their caregivers when they are in pain. In a pilot study, we showed that heart rate (HR) monitoring may identify painful situations in this patient group, as HR increases in acutely painful situations.

OBJECTIVES

This study aims to generate knowledge to reduce the number of painful episodes in non-communicative patients' everyday lives. We will 1) assess the effectiveness of HR as a tool for identifying potentially painful care procedures, 2) test the effect of HR-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.

METHODS

We will recruit 38 non-communicative patients with autism and ID residing in care homes.

ASSESSMENTS

HR is measured continuously to identify acutely painful situations. HR variability and pain-related cytokines (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) are collected as measures of long-term pain. Caregivers will be asked to what degree they observe pain in their patients and how well they believe they understand their patient's expressions of emotion and pain. Pre-intervention: HR is measured 8 h/day over 2 weeks to identify potentially painful situations across four settings: physiotherapy, cast use, lifting, and personal hygiene.

INTERVENTION

Changes in procedures for identified painful situations are in the form of changes in 1) physiotherapy techniques, 2) preparations for putting on casts, 3) lifting techniques or 4) personal hygiene procedures.

DESIGN

Nineteen patients will start intervention in week 3 while 19 patients will continue data collection for another 2 weeks before procedure changes are introduced. This is done to distinguish between specific effects of changes in procedures and non-specific effects, such as caregivers increased attention.

DISCUSSION

This study will advance the field of wearable physiological sensor use in patient care.

TRIAL REGISTRATION

Registered prospectively at ClinicalTrials.gov (NCT05738278).

摘要

背景

自闭症患者的沟通能力下降。大约 30%的自闭症患者存在智力障碍(ID)。一些自闭症和 ID 患者几乎无法交流,无法在感到疼痛时通知护理人员。在一项试点研究中,我们发现心率(HR)监测可以在这个患者群体中识别疼痛情况,因为在急性疼痛情况下 HR 会增加。

目的

本研究旨在减少非交流患者日常生活中的疼痛发作次数,为此我们将:1)评估 HR 作为识别潜在疼痛护理程序的工具的有效性,2)测试潜在疼痛护理程序中 HR 信息变化对疼痛生物标志物的影响,以及 3)评估通过 HR 进行六周沟通对患者和护理人员之间沟通质量的影响。

方法

我们将招募 38 名居住在护理院的非交流自闭症和 ID 患者。

评估

连续测量 HR 以识别急性疼痛情况。收集 HR 变异性和与疼痛相关的细胞因子(MCP-1、IL-1RA、IL-8、TGFβ1 和 IL-17)作为长期疼痛的衡量标准。护理人员将被要求评估他们在患者身上观察到的疼痛程度以及他们认为自己理解患者表达的情感和疼痛的程度。干预前:在 2 周内每天测量 8 小时 HR,以识别四个环境中的潜在疼痛情况:物理治疗、使用石膏、抬起和个人卫生。

干预

针对识别出的疼痛情况的程序变更形式为:1)物理治疗技术的变更,2)打石膏前的准备,3)抬举技术或 4)个人卫生程序的变更。

设计

19 名患者将在第 3 周开始干预,而 19 名患者将在引入程序变更前再进行 2 周的数据收集。这样做是为了区分程序变更的特定效果和非特定效果,例如护理人员增加了注意力。

讨论

本研究将推进可穿戴生理传感器在患者护理中的应用领域。

试验注册

在 ClinicalTrials.gov 上进行了前瞻性注册(NCT05738278)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/ec8a3f064c84/12888_2023_4757_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/dd1a09e6d4fe/12888_2023_4757_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/dd1a09e6d4fe/12888_2023_4757_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/3633924838e2/12888_2023_4757_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/4cf4df80e60f/12888_2023_4757_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7121/10103503/325f69364f67/12888_2023_4757_Fig4_HTML.jpg
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