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Active Not Recruiting NCT07709221

Effects of Hirudotherapy, Phytotherapy, and Forest Therapy in Adults With Reduced Work Capacity or Special Needs

Conditions: Participation Level Below 55% and/or Special Needs

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Klaipėda University

Location: Klaipeda University, Faculty of Health Sciences Klaipėda Klaipėda County

Summary

This interventional study will evaluate the effects of three complementary and alternative health care services-forest therapy, phytotherapy, and hirudotherapy-in individuals with a participation level below 55% and/or special needs. Participants will be assigned to one of three intervention groups or to a control group. The study will assess changes in blood pressure, body composition, handgrip strength, psychological well-being, perceived stress, and sleep quality before and after the intervention period. Safety, accessibility, feasibility, and acceptability of the services will also be evaluated. The findings will be used to develop standardized and evidence-informed recommendations for providing these services to people with reduced participation and/or special needs.

Eligibility Criteria

Inclusion Criteria: Individuals with a participation level below 55% and/or officially recognized special needs. Ability and willingness to participate in the study procedures and assigned intervention. Provision of written informed consent by the participant or, where applicable, by a legally authorized representative. Ability to complete the planned assessments independently or with reasonable assistance. Medical condition sufficiently stable to participate in the assigned complementary and alternative health care intervention. Willingness to attend baseline and post-intervention assessments and the scheduled intervention sessions. Exclusion Criteria: Acute illness, fever, active infection, or clinically unstable health condition at the time of enrollment. Any medical condition that, in the investigator's or intervention provider's judgment, would make participation unsafe. Known contraindication to the intervention to which the participant may be assigned. Current participation in another interventional study that could affect the study outcomes. Inability to provide informed consent and absence of a legally authorized representative. Inability to comply with the study procedures or intervention schedule despite reasonable accommodations. Planned major medical procedure or substantial change in treatment during the study period that could influence the study outcomes. Additional intervention-specific exclusion criteria: Phytotherapy: known allergy or hypersensitivity to the planned herbal products; clinically relevant interactions with current medications; pregnancy or breastfeeding, when relevant to the selected herbal product; severe hepatic or renal impairment where the planned preparation may be contraindicated. Hirudotherapy: bleeding disorders; clinically significant anemia; current anticoagulant or antiplatelet therapy when considered unsafe by the treating clinician; immunodeficiency; active skin infection or lesion at the planned application site; known allergy to leech-related substances; other contraindications identified by the licensed hirudotherapy practitioner. Forest therapy: acute condition limiting safe participation outdoors; uncontrolled cardiovascular or respiratory symptoms; severe mobility, cognitive, behavioral, or sensory limitations that cannot be safely accommodated; severe allergy or environmental sensitivity relevant to the planned setting. \-

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07709221). StuddyBuddy aggregates publicly available trial information.