The Effectiveness and Safety of Using Lithuania's Natural Resources to Improve Stress-related Mental and Physical Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- PSS-10 (Perceived Stress Scale)
研究概览
简要总结
High levels of stress cause serious health problems and reduce the quality of life. There is a lack of research proving the use of natural resources for the treatment or prevention of the stress and recovery from post Covid-19 condition. The goal of research: to assess the impact of natural resources (geothermal/mineral water, mud, salt, climate) on reducing stress and improving stress-related mental and physical health, as well as the safety of the procedures. The study will be randomized, controlled, parallel group, single- blinded (to researchers). The complex of procedures of water pool, mineral water bath, mud wrapping, salt therapy, nature therapy procedure will be provided with the different duration and mode (inpatient, outpatient). Primary outcomes- the effect on stress level; secondary outcomes: the effects on stress-related mental and physical health, work and social adaptation, tolerance and safety of balneotherapy procedures. The observation: before, after treatment, after 3 and 6 month of follow-up will be reveled.
详细描述
The burden of stress and the consequences of Covid-19 pandemia complicates the existing capacities of the health care system and harms the efficiency and economy, therefore effective strategies are needed to reduce the consequences by creating science-based methodologies to strengthen and restore health in resorts, which would encourage wellness services, using the unique natural resources available in Lithuanian resorts and resort areas, development and would allow to compete with the most advanced European health and rehabilitation centers.
Objectives of biomedical research:
- To assess the effectiveness of Lithuania's unique natural resources in reducing stress and improving stress-related mental and physical conditions.
- After identifying the group of those who have recovered from Covid-19, evaluate the effectiveness of natural factors for improving this condition.
- To present methodological recommendations for the use of Lithuania's natural resources.
Hypotheses of biomedical research:
- It is likely that a complex of procedures using natural resources will reduce stress, anxiety, and depression.
- It is likely that procedures with nature factors improve work and social adaptation.
- The effect of natural resource therapy is effective regardless of the duration of treatment and season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The subject will be randomly assigned to the study group (I-VI) by a computer program after the initial examination (T0) at the study centers. Grouping will be done by a statistician. Coding/blinding will be done so that researchers, statisticians, etc. will not know which group the subject belongs to. After the initial screening, the completed questionnaires will be modally coded by a statistician. The researchers conducting the clinical trial will not know which group the subject belongs to.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18- 65 years
- •Strength of stress >3 (0 no stress - 10 unbearable stress, VAS) AND/OR
- •Stress control <7 (0- I can't control - 10- I control perfectly, VAS)
排除标准
- •Uncontrolled/decompensated systemic diseases (hematological, endocrine, rheumatological, renal, cardiovascular, digestive, pulmonary),
- •Active infection,
- •Malignant tumors,
- •Surgery or major trauma in the past year,
- •Impaired ability to walk,
- •Applied balneotherapy treatment during a 3-month period,
- •Pregnancy/lactation,
- •Bleeding,
- •Severe mental disorder.
研究组 & 干预措施
Short ambulatory balneotherapy (SAB)
Group I will be given a complex of balneological procedures: swimming pool 20 min, 34-36° mineral/geothermal water procedure 20 min, sapropel wrapping 20 min, salt therapy 25 min. Duration of treatment - 6 days, outpatient.
干预措施: Balneotherapy plus complex (Combination Product)
Long ambulatory balneotherapy (LAB)
Group II will be given a complex of balneological procedures as group I- swimming pool 20 min, 34-36° mineral/geothermal water procedure 20 min, sapropel wrapping 20 min, salt therapy 25 min.
Duration of treatment - 11 days, outpatient treatment.
干预措施: Balneotherapy plus complex (Combination Product)
Combined nature resources treatment (CNT)
Group III will be given a complex of balneological procedures like groups I and II plus natural therapy procedure developed by the researchers: a 45-minute walk in nature (forest, seaside), a complex of simple strength and breathing low-intensity exercises, sensory impulses (landscape , forest smells - aromatherapy, natural sounds of nature, collecting nature's goodies (berries, pine cones, leaves, etc.), awareness therapy, heliotherapy.
Duration - 11 days., outpatient treatment.
干预措施: Combined nature resources treatment (Combination Product)
Long inpatient balneotherapy (LIB)
Group IV will be accommodated in the research/resort center and will receive balneological treatment (as groups I and II).
Duration of treatment 11 days, inpatient treatment.
干预措施: Balneotherapy plus complex (Combination Product)
Nature therapy (NT)
Group V will be given only the natural therapy procedure (as in group III). Duration 11 days, outpatient, self-managed according instructions and training provided.
干预措施: Nature therapy procedure (Other)
Control
Group VI - the control group, the participants of which will not be given any procedures. Duration 11 days.
结局指标
主要结局
PSS-10 (Perceived Stress Scale)
时间窗: 6 month
It is a self-reported questionnaire to measure the degree to which situations in one's life. There are described 10 items which are appraised as stressful and participant should sign 1-4 points to each. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. ► Scores ranging from 0-13 would be considered low stress. ► Scores ranging from 14-26 would be considered moderate stress. ► Scores ranging from 27-40 would be considered high perceived stress.
Cortisol level in saliva
时间窗: Treatment (1- 2 weeks)
Specified amount of saliva is taken into dispenser and the amount of cortisol in it is tested in sertified laboratory (Germany). Higher cortisol numbers indicate higher stress levels.
General Symptom Distress Scale (GSDS)
时间窗: 6 month
The GSDS is a brief self-reported measure to assess intensity (0 (I don't have this symptom) - 10 scale (extremely bothersome) of specific symptoms relevant to stress. In the second section of the GSDS, participants are asked to provide a global rating of how distressing their symptoms are on a 10-point scale, with higher scores indicating more distress. In the third part, participants are asked to provide a global rating of how well they are able to manage their symptoms on a 10-point scale with higher scores indicating better ability to manage symptoms.
次要结局
- Anxiety by STAI-5- Spielberger State-Trait Anxiety Inventory(6 month)
- Work and social adjustment by WSAS (work and social adjustment scale)(6 month)
- Effect on depression- CESD-R (Center for Epidemiological Studies Depression Scale )(6 month)
- Effect on fatigue- FAS-10 (Fatigue scale)(6 month)
- The safety of balneotherapy(After treatment (1-2 weeks))
- Forced expiratory volume(6 month)
- Cognitive function(6 month)
- Forced vital capacity(6 month)
- Heart rate(6 month)
- Oxygen saturation(6 month)
- AIOS (Arizona Integrative Outcomes Scale)(6 month)
- Blood pressure(6 month)
- Skin condition(6 month)
- Sleep quality(6 month)
- Peak expiratory flow(6 month)
研究者
Lolita Rapoliene
Associate professor dr.
Klaipėda University