The Effectiveness of Natural Resources for Reducing Stress

NCT06018649 | Unknown

• 1 other identifier: BE-2-87
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distress, Emotional; COVID-19

Keywords

stress; balneotherapy; mineral water; peloids; mental state; cortisol; rehabilitation; spa therapy; hydrotherapy; nature therapy; resort medicine; health; natural resources

Outcome Measures

Primary Outcomes (3)

• General Symptom Distress Scale (GSDS)

  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.

  6 month

• PSS-10 (Perceived Stress Scale)

  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.

  6 month

• Cortisol level in saliva

  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.

  Treatment (1- 2 weeks)

Secondary Outcomes (15)

• Anxiety by STAI-5- Spielberger State-Trait Anxiety Inventory

  6 month

• Work and social adjustment by WSAS (work and social adjustment scale)

  6 month

• The safety of balneotherapy

  After treatment (1-2 weeks)

• Effect on depression- CESD-R (Center for Epidemiological Studies Depression Scale )

  6 month

• Effect on fatigue- FAS-10 (Fatigue scale)

  6 month

Study Arms (6)

Short ambulatory balneotherapy (SAB)

EXPERIMENTAL

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.

Combination Product: Balneotherapy plus complex

Long ambulatory balneotherapy (LAB)

EXPERIMENTAL

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.

Combination Product: Balneotherapy plus complex

Combined nature resources treatment (CNT)

EXPERIMENTAL

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.

Combination Product: Combined nature resources treatment

Long inpatient balneotherapy (LIB)

EXPERIMENTAL

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.

Combination Product: Balneotherapy plus complex

Nature therapy (NT)

ACTIVE COMPARATOR

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.

Other: Nature therapy procedure

Control

NO INTERVENTION

Group VI - the control group, the participants of which will not be given any procedures. Duration 11 days.

Interventions

Balneotherapy plus complex COMBINATION_PRODUCT

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°).

Long ambulatory balneotherapy (LAB); Long inpatient balneotherapy (LIB); Short ambulatory balneotherapy (SAB)

Combined nature resources treatment COMBINATION_PRODUCT

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).

Combined nature resources treatment (CNT)

Nature therapy procedure OTHER

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).

Nature therapy (NT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klaipėda University: lead
• Research Council of Lithuania: collaborator

Study Sites (1)

Klaipėda university

Klaipėda, LT-92294, Lithuania

Location

MeSH Terms

Conditions

COVID-19

Interventions

Balneology

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lolita Rapoliene, ass.prof.

  Klaipėda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor dr.

Model Details: In a parallel study 6 groups of participants will receive different interventions modalities (duration, procedures complex, inpatient/outpatient, control). Participants will be assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group will be randomized. There will be possibility to compare few treatments modalities results.

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 30, 2023
• Study Start: January 2, 2023
• Primary Completion: September 15, 2023
• Study Completion: March 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

LI (1)