FybromyalgiaForCareNCT07648563
Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients
A study testing Forest therapy in people with Fybromyalgia and Fibromyalgia (FM), run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate if Forest therapy can reduce pain levels and improve the quality of life related to the level of pain perceived in fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fybromyalgia, Fibromyalgia (FM)
- What is being tested?
- Forest therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to Aug 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- diagnosis of fibromyalgia (diagnosed by a rheumatologist according to ACR criteria)
- enrolled in the pain management program at the Intensive Care Unit of Cecina Hospital
- under treatment with painkillers
- without mobility limitations that prevent them from taking slow, easy walks lasting approximately 2.5 hours and covering approximately 2 km, willing to self-certify their ability to walk unassisted in an obstacle-free environment
- capable of understanding the purpose of the study and providing informed consent to participate.
Who cannot join
- Patients who have not been diagnosed with fibromyalgia
- Diagnosis of neoplastic disease
- Pregnant women
- Allergies to pollen and/or grasses and/or insect bites
- Active systemic disease
- Neurological disease
- Degenerative disease
- Infectious disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest
Cecina
About this study
Official title: A Monocentric, Randomized, Controlled, No-profit, Interventional Study on the Effects of Forest Therapy in Patients With Fibromyalgia
The goal of this clinical trial is to evaluate if Forest therapy can reduce pain levels and improve the quality of life related to the level of pain perceived in fibromyalgia patients.
The main question it aims to answer is:
Does frequenting certified forest environments, according to the principles and methods of Forest Therapy, produce positive effects on chronic pain and the consumption of painkillers? The study is part of the "Forest Therapy Project as a Broad-Spectrum Tool for Patients Affected by Fibromyalgia" funded by the Tuscany Region as part of the Complementary Medicine program for the three-year period 2025-2027. The project will be carried out thanks to the collaboration with the National Research Council - Institute for BioEconomy (CNR-IBE)
Read the detailed description
Participants will be divided into two groups. One group, called the "intervention group," will participate in experimental Forest Therapy sessions at an easily accessible forest site. Another group, called the "control group," will not be required to make any changes to their usual habits or activities.
The Forest Therapy sessions consist of short, slow walks, intentionally without significant physical exertion, along safe and easy paths. Led by clinical professionals such as doctors, psychologists, or psychotherapists from the Anesthesia and Intensive Care Unit of Cecina, the sessions include frequent breaks and encourage concentration on the sensory connection with the forest environment.
The study is randomized, so assignment to one of the two treatment groups above will follow a pre-defined random criterion.
During the study, all patients will follow standard therapeutic treatments specific to their condition.
- Conditions
- Fybromyalgia, Fibromyalgia (FM)
- Being tested
- Forest therapy
- Keywords
- fibromyalgia, forest therapy, pain, painkillers, therapy
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest therapyBehavioural
Each session of Forest therapy will be organized as follows: 1. Gathering at the meeting point with the participants, doctor, psychologist, and staff.
- Introduction of the psychologist and the planned activities - 5 minutes. 3. Administration of the STAI and POMS tests and preliminary physiological measurements - 30 minutes.
- Beginning of the activity: request to turn off the phone and minimize verbal exchanges.
Slow walking - 5 minutes. Visual perception - 15 minutes. Slow walking - 5 minutes. Auditory perception - 15 minutes. Slow walking - 5 minutes. Tactile perception - 15 minutes. Slow walking - 5 minutes. Olfactory perception - 15 minutes. Slow walking - 5 minutes. Perceptual and movement activity chosen by the participant - 20 minutes. 5. Walk back to the starting/ending point - 20 minutes. STAI-S and POMS test and final physiological measurements - 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Forest therapy | Experimental | The intervention will consist of Forest Therapy sessions, once a week for 12 consecutive weeks .
The Forest Therapy sessions will be held in the Tombolo di Cecina Biogenetic Nature Reserve during the first year and in the second year in the "Giardino Belora, Fiume Cecina" Protected Natural Area, Municipality of Riparbella (PI). Forest Therapy will consist of short, slow walks, intentionally without significant physical effort, along safe and easy trails, classified at the lower "Tourist" level on the Italian Alpine Club's trail difficulty scale, immersed in particularly valuable forest environments. Receives: Behavioral: Forest therapy |
| Control group | No intervention | The control groups will consist of a cohort of fibromyalgia patients randomized-like the intervention groups-according to the following stratification factors: age (<50 vs. ≥50 years); baseline VAS score (<60 vs. ≥60 mm), to ensure maximum homogeneity with the intervention groups. The same measures as those required for intervention group participants will be performed on them. Compared to the intervention group, participants will not be required to modify their normal habits and activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of perceived pain assessed using the Visual Analog Scale
Level of perceived pain assessed using the Visual Analog Scale (VAS), a validated gold standard for fibromyalgia and allowing for direct and comparable measurement. The Visual Analogue Scale is the most widely used method in medicine to measure the intensity of pain subjectively perceived by the patient. It is usually represented as a continuous line 10 centimetres long, the ends of which indicate two opposite conditions: left end (0): no pain ; right end (10): the worst pain imaginable. The patient fills in the instrument by making a mark on the line at the point corresponding to the pain he or she feels. The operator then measures the distance in millimetres (from 0 to 100) to obtain the score. Interpretation of the Scores (cut-off): based on various clinical studies, the values of the scale are generally divided into 4 ranges: 0 - 4 mm: no pain ; 5 - 44 mm: mild pain ; 45 - 74 mm: Moderate pain; 75 - 100 mm: Severe pain.
Measured: Up to the last follow-up 3 months after the end of the therapy
Secondary outcomes (10)
Impact of fibromyalgia on quality of life evaluated by the Revised Fibromyalgia Impact Questionnaire (FIQR)
The Revised Fibromyalgia Impact Questionnaire (FIQR) is a self-assessment questionnaire used to measure the impact of fibromyalgia on quality of life.
The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into 3 linked sets of domains (symptoms, function and overall impact of the disease) and the final score (0-100) is obtained by summing the values of the 3 domains. Four severity categories and their corresponding cutoffs have been identified: remission if final score ≤30, mild if final score >30 and ≤45, moderate if final score >46 and ≤65, severe if final score >65. The study will evaluate the change in the score of the FIQR in the 2 arms.
Measured: Up to the last follow-up 3 months after the end of the therapy
Extent of body pain evaluated by the "Widespread Pain Index" (WPI)
The Widespread Pain Index (WPI) is one of two key parameters used for the assessment and diagnosis of fibromyalgia. It measures the extent of body pain . The questionnaire asks the patient to indicate in which specific areas of the body they have felt pain during the last week. The list consists of 19 body areas. One point is assigned for each area where pain is present. The total score therefore ranges from 0 (no area) to 19 (all the body).
Measured: Up to the last the follow-up 3 months after the end of the therapy
Assessment of anxiety status using the State-Trait Anxiety Inventory scale (STAI questionnaires)
The State-Trait Anxiety Inventory (STAI) is a standardized psychometric scale for measuring anxiety. It is divided into two parts: 20 questions to assess trait anxiety (STAI-T) and 20 questions to assess state anxiety (STAI-S). The STAI is a 60-point scale (from 20 to 80) where 20 indicates the lowest level of anxiety and 80 the highest possible score.
Measured: From the beginning of the forest therapy session to the end of the session
Assess mood and emotional states using the Profile of Mood States" (POMS) questionnaire
The Profile of Mood States" (POMS) questionnaire is a psychological and psychiatric questionnaire used to assess mood and emotional states. It is used in the management of fibromyalgia to quantify the psychological impact (e.g., anxiety, depression, fatigue) and stress related to chronic pain. The test consists of a list of adjectives (typically 65 in the standard version) that describe feelings and emotions experienced "including today." The patient rates each adjective on a scale from 0 (not at all) to 4 (extremely). The questionnaire measures 6 mood dimensions: Tension-Anxiety (e.g., tense, anxious, nervous); Depression-Disappointment (e.g., unhappy, sad, hopeless); Truth-Hostility (e.g., angry, resentful, offended); Vigor-Activity (e.g., active, energetic, lively); Fatigue-Inertia (e.g., tired, exhausted, listless); Confusion-Disconcertment (e.g., confused, disoriented, forgetful).
Measured: From the beginning of the forest therapy session to the end of the session
Systolic and diastolic blood pressure in mmHg
Changes in systolic and diastolic blood pressure in mmHg
Measured: Up to the last follow-up 3 months after the end of the therapy
Heart Rate in ms
Heart Rate in ms
Measured: Up to the last follow-up 3 months after the end of the therapy
Heart Rate Variability Variation in ms
Heart Rate Variability Variation in ms
Measured: Up to the last follow-up at 3 months after the end of the therapy
Possible change in pain medication use at the end of the study (intervention groups vs. control groups).
Possible change in pain medication use at the end of the study (intervention groups vs. control groups).
Measured: Up to the last follow-up at 3 months after the end of the therapy
Dependence of the variation of the aforementioned scores and parameters on environmental variables
Dependence of the variation of the aforementioned scores and parameters on environmental variables (meteorological comfort, volatile organic pollutants and biogenic volatile organic compounds), assessed during the forestry therapy sessions for the intervention groups only
Measured: From the beginning of the forest therapy session to the end of the session
Measure the overall severity of symptoms using the Symptom Severity Scale questionnaire
The Symptom Severity Scale (SSS) is one of the two main measures used to evaluate and diagnose fibromyalgia. It measures the overall severity of symptoms. It is commonly calculated in conjunction with the WPI scale. The SSS scale assigns a score from 0 to 12, adding the two values: severity of the 3 main syntoms e general somatic syntoms:
- Severity of the 3 main symptoms (score from 0 to 3 for each): the level of disturbance perceived in the last week is assessed:
- Asthenia (chronic tiredness).
- Sleep seizures or non-restorative sleep.
- Cognitive symptoms (difficulty with memory or concentration, mental fog) (Assigned values: 0 = No problem; 1 = Mild/Moderate; 2 = Moderate/Considerable; 3 = Severe/Continuous) 2) General somatic symptoms (score from 0 to 3): the presence of other related disorders is assessed (e.g. headache/migraine, abdominal pain or cramps, depression). (Assigned values: 0 = No symptoms; 1 = Few symptoms; 2 = Moderate symptoms; 3 = Severe symptoms)
Measured: Up to the last follow-up 3 months after the end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FybromyalgiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ubaldo Riccucci, Azienda USL Toscana Nord Ovest
- Investigators
- Ubaldo Riccucci, Medical doctor, Principal investigator, Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648563
- Sponsor's protocol ID
- For.Care
- Acronym
- ForCare
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Randomized, Controlled, No-profit, Interventional Study on the Effects of Forest Therapy in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07648563
- Acronym / sponsor ID
- ForCare / For.Care
- Conditions
- Fybromyalgia, Fibromyalgia (FM)
- Keywords
- fibromyalgia, forest therapy, pain, painkillers, therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Jun 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.
The goal of this clinical trial is to evaluate if Forest therapy can reduce pain levels and improve the quality of life related to the level of pain perceived in fibromyalgia patients.
The main question it aims to answer is:
Does frequenting certified forest environments, according to the principles and methods of Forest Therapy, produce positive effects on chronic pain and the consumption of painkillers? The study is part of the "Forest Therapy Project as a Broad-Spectrum Tool for Patients Affected by Fibromyalgia" funded by the Tuscany Region as part of the Complementary Medicine program for the three-year period 2025-2027. The project will be carried out thanks to the collaboration with the National Research Council - Institute for BioEconomy (CNR-IBE)
Detailed description
Participants will be divided into two groups. One group, called the "intervention group," will participate in experimental Forest Therapy sessions at an easily accessible forest site. Another group, called the "control group," will not be required to make any changes to their usual habits or activities.
The Forest Therapy sessions consist of short, slow walks, intentionally without significant physical exertion, along safe and easy paths. Led by clinical professionals such as doctors, psychologists, or psychotherapists from the Anesthesia and Intensive Care Unit of Cecina, the sessions include frequent breaks and encourage concentration on the sensory connection with the forest environment.
The study is randomized, so assignment to one of the two treatment groups above will follow a pre-defined random criterion.
During the study, all patients will follow standard therapeutic treatments specific to their condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forest therapy | Experimental | Behavioral: Forest therapyThe intervention will consist of Forest Therapy sessions, once a week for 12 consecutive weeks . The Forest Therapy sessions will be held in the Tombolo di Cecina Biogenetic Nature Reserve during the first year and in the second year in the "Giardino Belora, Fiume Cecina" Protected Natural Area, Municipality of Riparbella (PI). Forest Therapy will consist of short, slow walks, intentionally without significant physical effort, along safe and easy trails, classified at the lower "Tourist" level on the Italian Alpine Club's trail difficulty scale, immersed in particularly valuable forest environments. |
| Control group | No intervention | –The control groups will consist of a cohort of fibromyalgia patients randomized-like the intervention groups-according to the following stratification factors: age (<50 vs. ≥50 years); baseline VAS score (<60 vs. ≥60 mm), to ensure maximum homogeneity with the intervention groups. The same measures as those required for intervention group participants will be performed on them. Compared to the intervention group, participants will not be required to modify their normal habits and activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- diagnosis of fibromyalgia (diagnosed by a rheumatologist according to ACR criteria)
- enrolled in the pain management program at the Intensive Care Unit of Cecina Hospital
- under treatment with painkillers
- without mobility limitations that prevent them from taking slow, easy walks lasting approximately 2.5 hours and covering approximately 2 km, willing to self-certify their ability to walk unassisted in an obstacle-free environment
Key exclusion criteria (8 listed)
- Patients who have not been diagnosed with fibromyalgia
- Diagnosis of neoplastic disease
- Pregnant women
- Allergies to pollen and/or grasses and/or insect bites
- Active systemic disease
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 |
|---|---|---|
| Forest therapyEach session of Forest therapy will be organized as follows: 1. Gathering at the meeting point with the participants, doctor, psychologist, and staff. 2. Introduction of the psychologist and the planned activities - 5 minutes. 3. Administration of the STAI and POMS tests and preliminary physiological measurements - 30 minutes. 4. Beginning of the activity: request to turn off the phone and minimize verbal exchanges. Slow walking - 5 minutes. Visual perception - 15 minutes. Slow walking - 5 minutes. Auditory perception - 15 minutes. Slow walking - 5 minutes. Tactile perception - 15 minutes. Slow walking - 5 minutes. Olfactory perception - 15 minutes. Slow walking - 5 minutes. Perceptual and movement activity chosen by the participant - 20 minutes. 5. Walk back to the starting/ending point - 20 minutes. STAI-S and POMS test and final physiological measurements - 30 minutes | Behavioural | Forest therapy |
Primary outcome
Level of perceived pain assessed using the Visual Analog Scale
Time frame: Up to the last follow-up 3 months after the end of the therapy
Level of perceived pain assessed using the Visual Analog Scale (VAS), a validated gold standard for fibromyalgia and allowing for direct and comparable measurement. The Visual Analogue Scale is the most widely used method in medicine to measure the intensity of pain subjectively perceived by the patient. It is usually represented as a continuous line 10 centimetres long, the ends of which indicate two opposite conditions: left end (0): no pain ; right end (10): the worst pain imaginable. The patient fills in the instrument by making a mark on the line at the point corresponding to the pain he or she feels. The operator then measures the distance in millimetres (from 0 to 100) to obtain the score. Interpretation of the Scores (cut-off): based on various clinical studies, the values of the scale are generally divided into 4 ranges: 0 - 4 mm: no pain ; 5 - 44 mm: mild pain ; 45 - 74 mm: Moderate pain; 75 - 100 mm: Severe pain.
10 secondary outcomes
Impact of fibromyalgia on quality of life evaluated by the Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Up to the last follow-up 3 months after the end of the therapy
Extent of body pain evaluated by the "Widespread Pain Index" (WPI)
Time frame: Up to the last the follow-up 3 months after the end of the therapy
Assessment of anxiety status using the State-Trait Anxiety Inventory scale (STAI questionnaires)
Time frame: From the beginning of the forest therapy session to the end of the session
Assess mood and emotional states using the Profile of Mood States" (POMS) questionnaire
Time frame: From the beginning of the forest therapy session to the end of the session
Systolic and diastolic blood pressure in mmHg
Time frame: Up to the last follow-up 3 months after the end of the therapy
Heart Rate in ms
Time frame: Up to the last follow-up 3 months after the end of the therapy
Heart Rate Variability Variation in ms
Time frame: Up to the last follow-up at 3 months after the end of the therapy
Possible change in pain medication use at the end of the study (intervention groups vs. control groups).
Time frame: Up to the last follow-up at 3 months after the end of the therapy
Dependence of the variation of the aforementioned scores and parameters on environmental variables
Time frame: From the beginning of the forest therapy session to the end of the session
Measure the overall severity of symptoms using the Symptom Severity Scale questionnaire
Time frame: Up to the last follow-up 3 months after the end of the therapy
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 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Fybromyalgia
Enrolling by invitationObservational study
Assessment of Pain Experience in Fibromyalgia
Pain, Fybromyalgia
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.
Ubaldo Riccucci, Medical doctor principal investigator
Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest therapy in people with Fybromyalgia and Fibromyalgia (FM), run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
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 8 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: opening soon, as of the sponsor's last update on 15 Jun 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 Italy. 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?
Contact Ubaldo Riccucci, Medical doctor (+39 3923809820, ubaldo.riccucci@uslnordovest.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of perceived pain assessed using the Visual Analog Scale (time frame: Up to the last follow-up 3 months after the end of the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.