High levels of stress cause serious health problems and reduce the quality of life. Thereis a lack of research proving the use of natural resources for the treatment orprevention 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 asthe safety of the procedures. The study will be randomized, controlled, parallel group,single- blinded (to researchers). The complex of procedures of water pool, mineral waterbath, mud wrapping, salt therapy, nature therapy procedure will be provided with thedifferent duration and mode (inpatient, outpatient). Primary outcomes- the effect onstress level; secondary outcomes: the effects on stress-related mental and physicalhealth, work and social adaptation, tolerance and safety of balneotherapy procedures. Theobservation: before, after treatment, after 3 and 6 month of follow-up will be reveled.
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:
1. To assess the effectiveness of Lithuania's unique natural resources in reducing
stress and improving stress-related mental and physical conditions.
2. After identifying the group of those who have recovered from Covid-19, evaluate the
effectiveness of natural factors for improving this condition.
3. To present methodological recommendations for the use of Lithuania's natural
resources.
Hypotheses of biomedical research:
1. It is likely that a complex of procedures using natural resources will reduce
stress, anxiety, and depression.
2. It is likely that procedures with nature factors improve work and social adaptation.
3. The effect of natural resource therapy is effective regardless of the duration of
treatment and season.
A multicenter, prospective, randomized controlled, single-blinded parallel group
scientific study will be made.
Participants: 330 participants experiencing increased and poorly controlled stress or
reduced sense of well-being in Klaipėda and Druskininkai territories (6 groups of 55
people each). Sampling is a probabilistic nest (cluster), in which each research
participant's entry into the sample is multi-stage, criterion-referenced. The sample size
required for statistically significant comparisons of the rehabilitation effect of the
means of quantitative variables before and after the procedures was calculated by the
G*Power program.
- The subject will be randomly assigned to the respective 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 (if applicable, a description is provided so that no one
(subjects, researchers, statisticians, etc.) will 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.
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.
Group II will be given a complex of balneological procedures as group I. Duration of
treatment - 11 days. Comparing the results of groups I and II will allow us to assess the
influence of treatment duration.
Group III will be given a complex of balneological procedures like groups I and II and a
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. Comparison of groups I and II will allow to evaluate the
influence of complex treatment, including nature therapy.
Group IV will be accommodated in the research center and will receive balneological
treatments (as groups I and II). Duration of treatment 11 days. Comparison of the effect
between groups I, II, III and IV will allow to assess the impact of inpatient
rehabilitation treatment relatively.
Group V will be given only the natural therapy procedure (as in group III). Duration 11
days The results will make it possible to evaluate the benefits of the natural therapy
procedure, which can be applied by the person himself to improve or restore health.
Comparison with the results of group II will allow to evaluate the benefits of treatment
with balneotherapy procedures in the institution.
Group VI - the control group, the participants of which will not be given any procedures.
Duration 11 days Comparison with groups II, IV, V will allow us to evaluate the
differences in the health effects of rehabilitation procedures and natural therapy
compared to no treatment.
During the study, the sociodemographic, clinical, health, body condition and safety
assessment data of the study participants will be collected. Data will be collected based
only on the information provided by the participant and the results obtained during the
study. The screening questionnaire will ask for gender, age, marital status, education,
place of residence, nature of work, length of service and earnings, information on the
occurrence of Covid-19 and the incidence of chronic diseases, lifestyle habits, the level
of stress experienced and methods of management, the sense of well-being experienced and
information , which is important when including in the study - the current exacerbation
of a chronic disease; morbidity from an oncological or infectious disease, severe form of
cardiovascular, nervous, mental, kidney disease or bleeding, recent surgery or major
trauma, limitation of movement function; possible pregnancy or breastfeeding; Intolerance
of balneotherapy treatment or thermal procedures applied during the 3-month period and
plans to leave in the next 6 months, which would not ensure your participation in the
entire study period.
During the study, objective measurements will be performed to determine the response of
various body systems: BP (blood pressure), HR (heart rate), SpO2 (pulsoxymetry),
spirometry, toe-to-floor distance, sit-to-reach test, dynamometry, body composition
analysis, waist circumference, salivary cortisol, cognitive test set (alertness, working
memory, spatial number search, logical reasoning). The results of the scales will be used
to evaluate the results of the study: for stress - the perceived stress scale (PSS) and
the General Distress Symptoms Scale (GSDS), for anxiety - the Anxiety and Restlessness
Inventory (STAI), for depression - the Center for Epidemiological Research Revised
Depression Scale (CESD-R-20), for fatigue - Multidimensional Fatigue Inventory (FAS), for
sleep - one-point sleep quality scale (SQS), for adaptation - Work and Social Adaptation
Scale (WSAS), for well-being - Arizona Integrative Outcomes Scale (AIOS), for general
health and well-being - health questionnaire, procedures security assessment
questionnaire.
Combination Product: Balneotherapy plus complex
The three groups of study (SAB, LAB, LIB) will get same balneotherapy intervention with
the difference in duration and mode (outpatient/inpatient). Balneotherapy plus complex
procedures: swimming pool with light exercises- 20 min (29-31°C), rest 15 min,
wrapping/bath with peloids (peat mud, sapropel)- 20 min (38-40°C), rest 20 min, mineral
water bath- 20 min (36-38°C), salt therapy- 25 min (humidity 35%, temperature about 22°).
Combination Product: Combined nature resources treatment
The participants of CNT group will be given combined treatment: nature therapy procedure
(45 min) and balneotherapy plus complex intervention procedures.
The nature therapy procedure was created by researchers by combining the principles of
nature therapy, mindfulness, wild nature therapy, kinesiology selecting actions suitable
for the season. A procedure instructions with specific steps will be prepared and given
to the research participant. The procedure will be performed for the first time by a
physiotherapist, the rest of the procedures are performed independently, following the
detailed procedure with written instructions given to the participants. Each day
participants will receive a message with a reminder to perform the natural therapy
procedure. Duration of procedure- 45 min, outside (seaside, forest).
Other: Nature therapy procedure
The participants of NT group will be given nature therapy procedure (45 min) created by
researchers by combining the principles of nature therapy, kinesiology, mindfulness, wild
nature therapy, selecting actions suitable for the season. A procedure instruction with
specific steps will be prepared and given to the research participant. The procedure will
be performed for the first time by a physiotherapist, the rest of the procedures are
performed independently, following the detailed procedure with written instructions given
to the participants. Each day participants will receive a message with a reminder to
perform the natural therapy procedure. Duration of procedure- 45 min, outside (seaside,
forest).
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Klaipėda university
Klaipėda 598098, Lithuania
Lolita Rapoliene, ass.prof., Principal Investigator
Klaipėda University