Effects of Hirudotherapy, Phytotherapy, and Forest Therapy in Adults With Reduced Work Capacity or Special Needs (CAM-HPMT)

July 13, 2026 updated by: Laura Zaliene, Klaipėda University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
    • Klaipėda County
      • Klaipėda, Klaipėda County, Lithuania, LT-92294
        • Klaipeda University, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phytotherapy Group
Participants assigned to this arm will receive three phytotherapy sessions delivered by a qualified complementary and alternative health care practitioner. The services will use legally permitted and appropriately sourced herbal products in accordance with Lithuanian professional and safety requirements. Physiological, functional, and psychosocial outcomes will be assessed before and after the intervention period.
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.
Experimental: Forest Therapy Group
Participants assigned to this arm will receive ten structured forest therapy sessions delivered by a qualified forest therapy practitioner. Sessions will be adapted to participants' functional abilities and special needs and will be conducted in accessible natural environments. Physiological, functional, and psychosocial outcomes will be assessed before and after 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.
Experimental: Hirudotherapy Group
Participants assigned to this arm will receive six hirudotherapy sessions delivered by a qualified and licensed hirudotherapy practitioner. Eligibility and contraindications will be assessed before treatment, and participant safety and adverse events will be monitored throughout the intervention period. Physiological, functional, and psychosocial outcomes will be assessed before and after the intervention period.
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.
No Intervention: Control Group
Participants assigned to this arm will not receive a study-related complementary and alternative health care intervention during the study period. They will undergo the same baseline and post-intervention assessments as participants in the intervention groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in resting systolic blood pressure from baseline to the post-intervention assessment. Blood pressure will be measured in millimeters of mercury (mmHg) using a standardized procedure. A lower post-intervention value compared with baseline will indicate a reduction in systolic blood pressure.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Diastolic Blood Pressure
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in resting diastolic blood pressure from baseline to the post-intervention assessment. Blood pressure will be measured in millimeters of mercury (mmHg) using a standardized procedure. A lower post-intervention value compared with baseline will indicate a reduction in diastolic blood pressure.
Baseline and after completion of the intervention period, approximately 3 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Psychological Well-Being Assessed With the WHO-5 Well-Being Index
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in psychological well-being from baseline to the post-intervention assessment, measured using the 5-item World Health Organization Well-Being Index (WHO-5). The raw score ranges from 0 to 25, with higher scores indicating better psychological well-being. The raw score may also be multiplied by 4 to obtain a percentage score ranging from 0 to 100.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Perceived Stress Assessed With the PSS-10
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in perceived stress from baseline to the post-intervention assessment, measured using the 10-item Perceived Stress Scale (PSS-10). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Sleep Quality Assessed With the Pittsburgh Sleep Quality Index
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in sleep quality from baseline to the post-intervention assessment, measured using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Handgrip Strength
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in maximal handgrip strength from baseline to the post-intervention assessment. Handgrip strength will be measured in kilograms using a hand dynamometer under standardized testing conditions. Higher values indicate greater grip strength.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Fat Percentage
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in body fat percentage from baseline to the post-intervention assessment, measured using a standardized body composition analyzer. Lower or higher values will be interpreted according to the participant's individual health status.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Weight
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in body weight from baseline to the post-intervention assessment. Body weight will be measured in kilograms using a standardized body composition analyzer, with participants assessed under comparable measurement conditions.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Mass Index
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in body mass index from baseline to the post-intervention assessment. Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m².
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Skeletal Muscle Mass
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in skeletal muscle mass from baseline to the post-intervention assessment. Skeletal muscle mass will be estimated in kilograms using a standardized bioelectrical impedance body composition analyzer under comparable measurement conditions.
Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Visceral Fat Level
Time Frame: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in visceral fat level from baseline to the post-intervention assessment. Visceral fat will be estimated using a standardized bioelectrical impedance body composition analyzer and reported according to the device-specific visceral fat rating scale. Lower scores indicate a lower estimated level of visceral fat.
Baseline and after completion of the intervention period, approximately 3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klaipėda University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Zaliene, PhD, Klaipėda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAM-SN-HFT-2026-01
  • SAM-003-K-0002 (Other Grant/Funding Number: Ministry of Health of the Republic of Lithuania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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