Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients (ForCare)
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)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ubaldo Riccucci, Medical doctor
- 전화번호: +39 3923809820
- 이메일: ubaldo.riccucci@uslnordovest.toscana.it
연구 장소
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Cecina, 이탈리아
- Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Forest therapy
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. |
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 |
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간섭 없음: Control group
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Level of perceived pain assessed using the Visual Analog Scale
기간: Up to the last follow-up 3 months after the end of the therapy
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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.
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Up to the last follow-up 3 months after the end of the therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Impact of fibromyalgia on quality of life evaluated by the Revised Fibromyalgia Impact Questionnaire (FIQR)
기간: Up to the last follow-up 3 months after the end of the therapy
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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. |
Up to the last follow-up 3 months after the end of the therapy
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Extent of body pain evaluated by the "Widespread Pain Index" (WPI)
기간: Up to the last the follow-up 3 months after the end of the therapy
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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).
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Up to the last the follow-up 3 months after the end of the therapy
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Assessment of anxiety status using the State-Trait Anxiety Inventory scale (STAI questionnaires)
기간: From the beginning of the forest therapy session to the end of the session
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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.
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From the beginning of the forest therapy session to the end of the session
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Assess mood and emotional states using the Profile of Mood States" (POMS) questionnaire
기간: From the beginning of the forest therapy session to the end of the session
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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).
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From the beginning of the forest therapy session to the end of the session
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Systolic and diastolic blood pressure in mmHg
기간: Up to the last follow-up 3 months after the end of the therapy
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Changes in systolic and diastolic blood pressure in mmHg
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Up to the last follow-up 3 months after the end of the therapy
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Heart Rate in ms
기간: Up to the last follow-up 3 months after the end of the therapy
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Heart Rate in ms
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Up to the last follow-up 3 months after the end of the therapy
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Heart Rate Variability Variation in ms
기간: Up to the last follow-up at 3 months after the end of the therapy
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Heart Rate Variability Variation in ms
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Up to the last follow-up at 3 months after the end of the therapy
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Possible change in pain medication use at the end of the study (intervention groups vs. control groups).
기간: Up to the last follow-up at 3 months after the end of the therapy
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Possible change in pain medication use at the end of the study (intervention groups vs. control groups).
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Up to the last follow-up at 3 months after the end of the therapy
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Dependence of the variation of the aforementioned scores and parameters on environmental variables
기간: From the beginning of the forest therapy session to the end of the session
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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
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From the beginning of the forest therapy session to the end of the session
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Measure the overall severity of symptoms using the Symptom Severity Scale questionnaire
기간: Up to the last follow-up 3 months after the end of the therapy
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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: 1) Severity of the 3 main symptoms (score from 0 to 3 for each): the level of disturbance perceived in the last week is assessed:
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Up to the last follow-up 3 months after the end of the therapy
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ubaldo Riccucci, Medical doctor, Anesthesia and Resuscitation Unit, Cecina Hospital - Azienda USL Toscana Nord Ovest
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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