Набор скоро начнётся NCT07648563

Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients

Без фазы С лечением Fybromyalgia Fibromyalgia (FM)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Forest therapy.
Кому может быть актуально: Состояния в реестре: Fybromyalgia, Fibromyalgia (FM). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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)

Подробное описание

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.

Вмешательства

Поведенческое 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

Первичные конечные точки

Level of perceived pain assessed using the Visual Analog Scale [Срок оценки: Up to the last follow-up 3 months after the end of the therapy]

Вторичные конечные точки (10)

Impact of fibromyalgia on quality of life evaluated by the Revised Fibromyalgia Impact Questionnaire (FIQR) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From the beginning of the forest therapy session to the end of the session]
Systolic and diastolic blood pressure in mmHg [Срок оценки: Up to the last follow-up 3 months after the end of the therapy]
Heart Rate in ms [Срок оценки: Up to the last follow-up 3 months after the end of the therapy]
Heart Rate Variability Variation in ms [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Up to the last follow-up 3 months after the end of the therapy]

Критерии участия

Критерии включения

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.