Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients

NCT07648563 | Not Yet Recruiting

• 1 other identifier: For.Care
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Fybromyalgia; Fibromyalgia (FM)

Keywords

fibromyalgia; forest therapy; pain; painkillers; therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  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

  From the beginning of the forest therapy session to the end of the session

• Systolic and diastolic blood pressure in mmHg

  Up to the last follow-up 3 months after the end of the therapy

Study Arms (2)

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.

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.

Interventions

Forest therapy BEHAVIORAL

Each 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

Forest therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead

Study Sites (1)

Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest

Cecina, Italy

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Ubaldo Riccucci, Medical doctor

  Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ubaldo Riccucci, Medical doctor

CONTACT

+39 3923809820; ubaldo.riccucci@uslnordovest.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)