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临床试验/NCT00909194
NCT00909194已完成不适用

Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population

Joel Thompson2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2007年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Joel Thompson
入组人数
132
试验地点
2
主要终点
To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS

研究概览

简要总结

The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this intervention in comparison to the control (skin care seminar).

详细描述

The specific aims of phase one of this study were to estimate the prevalence of Juvenile Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to identify characteristics associated with JPFS in this population. We chose to explore two primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and depression, we hypothesize that those with JPFS will score higher on measures of these symptoms. Given the adult literature on the suspected link between physical and or sexual abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for JPFS will have higher rates of sexual and physical abuse.

The other specific aim of this study was to determine the short- and long-term impact of an intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation technique (audio-guided CD). The control group was involved in an educational seminar on skin care (WITHOUT relaxation technique). Study measures were obtained immediately before and after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term). Each group was discharged with a CD player and CD with relaxation technique or skin care seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8 weeks after discharge from the hospital.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Admitted to inpatient child psychiatric facility
  • Between 12-18 years of age
  • in parental or family (relative as guardian) custody

排除标准

  • In state custody
  • low intellectual functioning (i.e. IQ less than or equal to 70)
  • active psychosis

研究组 & 干预措施

Intervention

Experimental

Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique

干预措施: Psychoeducational Seminar and Relaxation Technique (Behavioral)

Control

No Intervention

Control Arm consisted of an educational seminar on skin care

结局指标

主要结局

To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS

次要结局

  • To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)(Immediately after intervention and 8 weeks after discharge)

研究者

发起方
Joel Thompson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joel Thompson

Clinical trial compliance administrator

University of Kentucky

研究点 (2)

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