Authors
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Klaipeda University -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
This randomized controlled interventional study will evaluate the biological, functional,and psychosocial effects of complementary and alternative health care services inindividuals with a participation level below 55% and/or special needs. The study isdesigned to generate evidence for the development of standardized, accessible, andevidence‐informed protocols for forest therapy, phytotherapy, and hirudotherapy.A total of 100 participants will be enrolled and allocated to four groups ofapproximately 25 participants each: a phytotherapy group, a forest therapy group, ahirudotherapy group, and a control group receiving no study‐related complementary andalternative health care intervention. Participants in the phytotherapy group will receivethree phytotherapy sessions, participants in the forest therapy group will receive tenforest therapy sessions, and participants in the hirudotherapy group will receive sixhirudotherapy sessions. The interventions will be delivered by appropriately qualifiedand licensed practitioners in accordance with Lithuanian legal and professionalrequirements.Assessments will be conducted before and after the intervention period. Physiological andfunctional assessments will include blood pressure, body composition, and handgripstrength. Psychosocial outcomes will include psychological well‐being, perceived stress,and sleep quality, assessed using standardized questionnaires, including the WHO‐5Well‐Being Index, the 10‐item Perceived Stress Scale, and the Pittsburgh Sleep QualityIndex. Pre‐intervention and post‐intervention outcomes will be compared within andbetween the intervention and control groups.The study will also evaluate the feasibility, accessibility, safety, and acceptability ofproviding 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 whenrequired.Participant safety will be monitored throughout the study. Eligibility,contraindications, and potential risks will be assessed before the interventions. Anyadverse events or unexpected reactions will be documented and evaluated. Particularattention will be given to contraindications and safety requirements associated withphytotherapy and hirudotherapy.The results will be used to prepare standardized methodological materials and practicalrecommendations for complementary and alternative health care practitioners, healthpromotion programs, and social inclusion services.
Epistemonikos ID: 75558171f0190ee3721c52d421ce4a4879701875
First added on: Jul 16, 2026