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临床试验/NCT01681056
NCT01681056已完成不适用

Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion

Indonesia University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life.

The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.

详细描述

Geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. Autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and control groups received usual standard medical therapy.

Baseline data were collected within one week after admission. Then the subject will be followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2, interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system by Magnetic Resonance Spectroscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 60 years old with multipathology, inpatients
  • Not in steroid therapy
  • Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)
  • Cooperative
  • Willing to go through all of the research steps.

排除标准

  • Multiple Sclerosis
  • Brain Tumour
  • Using Pace maker

结局指标

主要结局

Quality of Life

时间窗: 30 days

Measured by COOP chart

次要结局

  • Interleukin-6 (pg/mL)(30 days)
  • Interleukin-2 (pg/mL)(30 days)
  • Serum Cortisol (ng/mL)(30 days)
  • Interferon Gamma (pg/mL)(30 days)
  • N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Kemala Sari, MD

Medical Doctor

Indonesia University

研究点 (2)

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