跳至主要内容
临床试验/NCT05409859
NCT05409859已完成不适用

Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study

Université du Québec à Trois-Rivières1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Delayed adverse event

研究概览

简要总结

This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger. A validated reporting system will be used to evaluate the adverse events and include a total of four questionnaires that are filled online. Adverse events will be evaluated immediately following the intervention and at 48h post-intervention.

详细描述

The aim of this study is to investigate (1) the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger and (2) to report preliminary data on the frequency and nature of the adverse events. Participating chiropractors will advertise the study in their private clinic through flyers and posters. Legal tutors interested to participate will access an information sheet and consent form using a link available on the flyers/posters. Legal tutors of participants will complete three questionnaires, one before the intervention to describe the child (e.g. age, sex, reason(s) to seek care), one immediately following the intervention to report immediate adverse events and one 48h following the intervention to report delayed adverse events. Clinicians will complete one questionnaire immediately following the intervention to describe the manual therapies delivered to the children. All questionnaires will be available online on a secured platform. The intervention will be determined by the clinician according the their evaluation of the child and could include spinal mobilization as well as soft tissue therapies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of 5 years or younger
  • First or second treatment at one of the chiropractic clinic
  • Spinal mobilization has to be clinically indicated

排除标准

  • Children of 6 years or older
  • Spinal mobilization not indicated

结局指标

主要结局

Delayed adverse event

时间窗: 48 hours following the intervention

New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies

Immediate adverse event

时间窗: 5 minutes following the intervention

New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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