Participation Level Below 55% and/or Special NeedsCAM-HPMTNCT07709221
Effects of Hirudotherapy, Phytotherapy, and Forest Therapy in Adults With Reduced Work Capacity or Special Needs
A study testing Phytotherapy, Forest Therapy and Hirudotherapy in people with Participation Level Below 55% and/or Special Needs, run by Klaipėda University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Participation Level Below 55% and/or Special Needs
- What is being tested?
- Phytotherapy, Forest Therapy and Hirudotherapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Apr 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Klaipeda University, Faculty of Health Sciences
Klaipėda, Klaipėda County, LT-92294
About this study
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
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.
Read the 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.
- Being tested
- Phytotherapy, Forest Therapy, Hirudotherapy
- Keywords
- Complementary and Alternative Health Care, Forest Therapy, Phytotherapy, Hirudotherapy, Special Needs, Reduced Participation, Psychological Well-Being, Perceived Stress, Sleep Quality, Blood Pressure, Handgrip Strength
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytotherapyOther
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.
Forest TherapyBehavioural
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.
HirudotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Phytotherapy Group | Experimental | 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. Receives: Other: Phytotherapy |
| Forest Therapy Group | Experimental | 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. Receives: Behavioral: Forest Therapy |
| Hirudotherapy Group | Experimental | 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. Receives: Procedure: Hirudotherapy |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Diastolic Blood Pressure
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Secondary outcomes (9)
Change in Psychological Well-Being Assessed With the WHO-5 Well-Being Index
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Perceived Stress Assessed With the PSS-10
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Sleep Quality Assessed With the Pittsburgh Sleep Quality Index
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Handgrip Strength
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Fat Percentage
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Weight
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Body Mass Index
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Skeletal Muscle Mass
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Change in Visceral Fat Level
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.
Measured: Baseline and after completion of the intervention period, approximately 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start15 Apr 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Participation Level Below 55% and/or Special NeedsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of four parallel groups: phytotherapy, forest therapy, hirudotherapy, or a control group receiving no study-related complementary and alternative health care intervention. Each participant will remain in the assigned group throughout the study, and outcomes will be assessed before and after the intervention period.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klaipėda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Zaliene, Klaipėda University
- Investigators
- Laura Zaliene, PhD, Principal investigator, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709221
- Sponsor's protocol ID
- CAM-SN-HFT-2026-01
- Other IDs
- SAM-003-K-0002
- Acronym
- CAM-HPMT
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siah CJR, Goh YS, Lee J, Poon SN, Ow Yong JQY, Tam WW. The effects of forest bathing on psychological well-being: A systematic review and meta-analysis. Int J Ment Health Nurs. 2023 Aug;32(4):1038-1054. doi: 10.1111/inm.13131. Epub 2023 Mar 2.
PubMed 36864583Qiu Q, Yang L, He M, Gao W, Mar H, Li J, Wang G. The Effects of Forest Therapy on the Blood Pressure and Salivary Cortisol Levels of Urban Residents: A Meta-Analysis. Int J Environ Res Public Health. 2022 Dec 27;20(1):458. doi: 10.3390/ijerph20010458.
PubMed 36612777Hosseini M, Jadidi A, Derakhshan Barjoei MM, Salehi M. Applications of leech therapy in medicine: a systematic review. Front Med (Lausanne). 2024 Sep 16;11:1417041. doi: 10.3389/fmed.2024.1417041. eCollection 2024.
PubMed 39351007Lauche R, Cramer H, Langhorst J, Dobos G. A systematic review and meta-analysis of medical leech therapy for osteoarthritis of the knee. Clin J Pain. 2014 Jan;30(1):63-72. doi: 10.1097/AJP.0b013e31828440ce.
PubMed 23446069
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07709221
- Acronym / sponsor ID
- CAM-HPMT / CAM-SN-HFT-2026-01
- Keywords
- Complementary and Alternative Health Care, Forest Therapy, Phytotherapy, Hirudotherapy, Special Needs, Reduced Participation, Psychological Well-Being, Perceived Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klaipėda UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to one of four parallel groups: phytotherapy, forest therapy, hirudotherapy, or a control group receiving no study-related complementary and alternative health care intervention. Each participant will remain in the assigned group throughout the study, and outcomes will be assessed before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Phytotherapy Group | Experimental | Other: PhytotherapyParticipants 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. |
| Forest Therapy Group | Experimental | Behavioral: Forest TherapyParticipants 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. |
| Hirudotherapy Group | Experimental | Procedure: HirudotherapyParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhytotherapyParticipants 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. | Other | Phytotherapy Group |
| Forest TherapyParticipants 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. | Behavioural | Forest Therapy Group |
| HirudotherapyParticipants 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. | Procedure or surgery | Hirudotherapy Group |
Primary outcome
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.
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.
9 secondary outcomes
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 Perceived Stress Assessed With the PSS-10
Time frame: 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 Handgrip Strength
Time frame: 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 Weight
Time frame: 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 Skeletal Muscle Mass
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication: PubMed 36864583Siah CJR, Goh YS, Lee J, Poon SN, Ow Yong JQY, Tam WW. The effects of forest bathing on psychological well-being: A systematic review and meta-analysis. Int J Ment Health Nurs. 2023 Aug;32(4):1038-1054. doi: 10.1111/inm.13131. Epub 2023 Mar 2.
- Results publication: PubMed 36612777Qiu Q, Yang L, He M, Gao W, Mar H, Li J, Wang G. The Effects of Forest Therapy on the Blood Pressure and Salivary Cortisol Levels of Urban Residents: A Meta-Analysis. Int J Environ Res Public Health. 2022 Dec 27;20(1):458. doi: 10.3390/ijerph20010458.
- Results publication: PubMed 39351007Hosseini M, Jadidi A, Derakhshan Barjoei MM, Salehi M. Applications of leech therapy in medicine: a systematic review. Front Med (Lausanne). 2024 Sep 16;11:1417041. doi: 10.3389/fmed.2024.1417041. eCollection 2024.
- Results publication: PubMed 23446069Lauche R, Cramer H, Langhorst J, Dobos G. A systematic review and meta-analysis of medical leech therapy for osteoarthritis of the knee. Clin J Pain. 2014 Jan;30(1):63-72. doi: 10.1097/AJP.0b013e31828440ce.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Zaliene, PhD principal investigator
Klaipėda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytotherapy, Forest Therapy and Hirudotherapy in people with Participation Level Below 55% and/or Special Needs, run by Klaipėda University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (time frame: Baseline and after completion of the intervention period, approximately 3 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07709221, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.