Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda USL Toscana Nord Ovest

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who have not been diagnosed with fibromyalgia

Diagnosis of neoplastic disease

Pregnant women

Allergies to pollen and/or grasses and/or insect bites

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Forest therapyExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Up to the last follow-up 3 months after the end of the therapy
2

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).

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

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.

Time frame
From the beginning of the forest therapy session to the end of the session
4

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).

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

Other outcomes

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