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NCT07709221

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

Sponsor: Klaipėda University

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Biological Effects of Complementary and Alternative Health Care Services, Including Forest Therapy, Phytotherapy, and Hirudotherapy, in Individuals With Reduced Work Capacity and/or Special Needs

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-15

Completion Date

2026-12-20

Last Updated

2026-07-16

Healthy Volunteers

Conditions

Participation Level Below 55% and/or Special Needs

Interventions

OTHER

Phytotherapy

Participants assigned to the phytotherapy arm will receive three individualized phytotherapy sessions delivered by a qualified complementary and alternative health care practitioner. The intervention may include assessment, selection, and use of legally permitted herbal preparations or herbal products appropriate to the participant's health status and special needs. Products will not be presented as investigational medicinal products. Contraindications, possible interactions, tolerability, and adverse reactions will be assessed and monitored throughout the intervention period.

BEHAVIORAL

Forest Therapy

Participants assigned to the forest therapy arm will receive ten structured forest therapy sessions delivered by a qualified forest therapy practitioner. Sessions will take place in accessible natural or forest environments and may include guided slow walking, sensory awareness, breathing, relaxation, mindful attention, and reflective activities. Session content and pace will be adapted to participants' functional abilities and special needs. Attendance, tolerability, and any adverse events will be documented.

PROCEDURE

Hirudotherapy

Participants assigned to the hirudotherapy arm will receive six hirudotherapy sessions delivered by a qualified and licensed practitioner. Before the intervention, eligibility and contraindications will be assessed. Medicinal leeches will be applied according to an individualized protocol, taking into account the participant's health condition and safety requirements. Participants will be monitored for bleeding, local skin reactions, infection, allergic reactions, and other adverse events during and after each session.

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. \-

Locations (1)

Klaipeda University, Faculty of Health Sciences

Klaipėda, Klaipėda County, Lithuania