Assessment of Effectiveness of the Osteopathic Sympathetic Harmonization Applications on the Sympathetic Nervous System and the HPA Axis With Depression Diagnosed Adolescents: A Double-blind, Placebo-controlled, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change from Baseline Salivary Biomarkers at 20 minutes
研究概览
简要总结
Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.
详细描述
Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind trial
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- •Volunteering to participate in the study
排除标准
- •Fever over 38.5
- •Acute injury or infection
- •Rib fracture
- •Cardiac arrhythmia
- •Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
- •Being pregnant, premenstrual or in the menstrual period for female participants
结局指标
主要结局
Change from Baseline Salivary Biomarkers at 20 minutes
时间窗: Before intervention, immediately after the intervention, 20 second after the intervention
Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.
Demographic data
时间窗: Before intervention
Sex; male or female
The Beck Depression Inventory (BDI)
时间窗: Before intervention
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Change from Baseline Heart rate and blood pressure measurements at 20 minutes
时间窗: Before intervention, immediately after the intervention, 20 minutes after the intervention
Heart rate (beats per minute) and blood pressure (mm/Hg) were measured with automatic blood pressure monitor (the Microlife BP 3BT0-A). It is a clinically validated and 1-star automatic blood pressure monitor
The State-Trait Anxiety Inventory (STAI) Form - 1
时间窗: Before intervention
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes
时间窗: Before intervention, immediately after the intervention, 20 minutes after the intervention
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
次要结局
未报告次要终点
研究者
Ömer Osman PALA
Assistant Professor
Cumhuriyet University