跳至主要内容
临床试验/CTRI/2022/04/042247
CTRI/2022/04/042247尚未招募不适用

Trauma antecedents, alexithymia and quality of life in persons with primary and secondary chronic pain

Government Medical College and Hospital1 个研究点 分布在 1 个国家入组 60 人开始时间: 2022年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Trauma Antecedents in Chronic Pain

研究概览

简要总结

Chronic pain is an emerging public health problem impacting large number of individuals but is poorly understood in terms of mechanisms and causes. Very few studies have been conducted that study the role of trauma antecedents in the development or maintenance of chronic pain. There is enough literature that establishes linkages between trauma, alexithymia and chronic pain separately but there is a need to study them together. Almost all previous research has limited itself to either a specific gender, condition, culture and the variables have been studied only in pairs. There exists no published study that looks at the association between all three variables in chronic pain conditions. The present study aims to bridge that gap by exploring associations among all the three variables and comparing them across the two conditions. According to the literature review conducted, almost all studies have focused on specific chronic pain disorders due to increased heterogeneity. However, recent discourse around chronic pain points towards a classification of these syndromes as over-arching chronic pain as they might have similar etiology and clinical presentations. Thus, there is a need to evaluate chronic pain as a distinct, independent condition. There is also a deficit in research studies that compare primary chronic pain conditions to other kinds of chronic pain. The current study can have treatment implications as traumatic histories, alexithymia and quality of life are important domains for a holistic assessment and significantly determine the course of treatment.

研究设计

研究类型
观察性

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)

入选标准

  • Individuals having chronic pain for more than 3 months Age Range: 20-55 years Education Level: 10th and above Any Gender.

排除标准

  • Individuals with major psychiatric disorders such as psychosis, bipolar affective disorders, substance dependence disorder (except nicotine & caffeine), obsessive compulsive disorder, eating disorders Individuals with a history of migraine disorder Individuals having co-morbid medical conditions requiring treatment or undergoing treatment.

结局指标

主要结局

Trauma Antecedents in Chronic Pain

时间窗: At the end of Data Collection (3 months)

次要结局

  • Alexithymia and Quality of Life(At the end of data collection (3 months))

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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标识符

CTRI 编号
CTRI/2022/04/042247

日期

最近更新
(4年前)

监管与共享

个体参与者数据共享计划
是

Will individual participant data (IPD) be shared publicly (including data dictionaries)?   Response  - YES What data in particular will be shared? Response  - All of the individual participant data collected during the trial, after de-identification. What additional supporting information will be shared? Response  -  Study Protocol Response  -  Statistical Analysis Plan Who will be able to view these files? Response  - Anyone For what types of analyses will this data be available? Response  - Any purpose. By what mechanism will data be made available? Response (Others)  -  For how long will this data be available start date provided 01-04-2023 and end date provided 16-05-2023 ? Response  - Immediately following publication. No end date. Any URL or additional information regarding plan/policy for sharing IPD?  Additional Information  - NIL

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