Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients

Official title

A Monocentric, Randomized, Controlled, No-profit, Interventional Study on the Effects of Forest Therapy in Patients With Fibromyalgia

Overview

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.

Interventions

• Behavioral Forest therapy
  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

Primary outcome measures

• 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]

Secondary outcome measures (10)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

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

Identifiers

NCT: NCT07648563 · For.Care

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗