Acupoint Thermal Radiation Characteristics in Adolescents with Major Depressive Disorder and Establishment of Diagnostic Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acupoint emperature
研究概览
简要总结
Modern studies have confirmed that skin temperature changes at acupoints when the body is under pathological conditions. This suggests that changes in the thermal radiation characteristics of acupoints can objectively respond to the symptoms of a disease. In this study, the investigators first evaluated reproducibility of acupoint temperature measurement by IRT. Secondly, the investigators explored the thermal radiation characteristics of MDD-related acupoints, built the diagnostic model for adolescent depression severity and the diagnostic model for MDD in adolescents based on acupoint temperature. Our research findings will provide new ideas, methods and visualisations for early screening, auxiliary diagnosis and condition assessment of MDD in adolescents.
详细描述
A total of 100 subjects were included, 60 adolescent with MDD (MDD group) and 40 healthy controls (HC group). All subjects accepted IRT detection.The random selection of 30 adolescent with MDD allowed the collection of the bilateral same name acupoint temperatures. Intra- and inter-observer reproducibility for the patients were examined in some randomly selected patients by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the healthy control participants:
- •12years≤ age<18 years;
- •SDS score <53;
- •Adolescents with normal cognitive function can cooperate with the study;
- •Adolescents and guardians agree to the study plan and sign the informed consent form.
- •Inclusion criteria for the major depression disorder participants:
- •12years≤ age<18 years;
- •Self-rating Depression Scale (SDS) score ≥ 53;
- •Language, cognition and communication ability are normal;
- •Patients and guardians agree to the study plan and sign the informed consent form.
排除标准
- •Exclusion criteria both for the healthy control participants and major depression disorder participants:
- •Severe anxiety, schizophrenia, or other serious mental illnesses;
- •There are pigmentation, redness, infection or scarring on the skin at the site of detection;
- •Patients with severe systemic diseases and their complications, serious infections, and major diseases of viscera, tissues, and systems;
- •Female patients who were pregnant or lactating;
- •Female patients who were during, or in proximity (±2 days) to their menstruation or ovulation;
- •Patients with a body temperature ≥37.3°C;
- •Inability to cooperate during the examination;
- •Participating in any other clinical trials.
结局指标
主要结局
Acupoint emperature
时间窗: Baseline
Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.
次要结局
- The Self-Rating Depression Scale (SDS) Scores(Baseline)
研究者
Xiaomei Shao
Prof
The Third Affiliated hospital of Zhejiang Chinese Medical University