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

This randomized controlled interventional study will evaluate the biological, functional, and psychosocial effects of complementary and alternative health care services in individuals with a participation level below 55% and/or special needs. The study is designed to generate evidence for the development of standardized, accessible, and evidence-informed protocols for forest therapy, phytotherapy, and hirudotherapy.

A total of 100 participants will be enrolled and allocated to four groups of approximately 25 participants each: a phytotherapy group, a forest therapy group, a hirudotherapy group, and a control group receiving no study-related complementary and alternative health care intervention. Participants in the phytotherapy group will receive three phytotherapy sessions, participants in the forest therapy group will receive ten forest therapy sessions, and participants in the hirudotherapy group will receive six hirudotherapy sessions. The interventions will be delivered by appropriately qualified and licensed practitioners in accordance with Lithuanian legal and professional requirements.

Assessments will be conducted before and after the intervention period. Physiological and functional assessments will include blood pressure, body composition, and handgrip strength. Psychosocial outcomes will include psychological well-being, perceived stress, and sleep quality, assessed using standardized questionnaires, including the WHO-5 Well-Being Index, the 10-item Perceived Stress Scale, and the Pittsburgh Sleep Quality Index. Pre-intervention and post-intervention outcomes will be compared within and between the intervention and control groups.

The study will also evaluate the feasibility, accessibility, safety, and acceptability of providing these services to individuals with reduced participation and/or special needs. Reasonable accommodations may include accessible locations, adapted information formats, assistance with transportation or mobility, and support from accompanying persons when required.

Participant safety will be monitored throughout the study. Eligibility, contraindications, and potential risks will be assessed before the interventions. Any adverse events or unexpected reactions will be documented and evaluated. Particular attention will be given to contraindications and safety requirements associated with phytotherapy and hirudotherapy.

The results will be used to prepare standardized methodological materials and practical recommendations for complementary and alternative health care practitioners, health promotion programs, and social inclusion services.

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.

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