Nature-based Sensory Stimulation on Pain Levels

Study Overview
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Brief Summary
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This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

Detailed Description
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All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Official Title
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The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Nature-based sensory stimuli
* Other: Control group intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of fibromyalgia syndrome (ACR criteria 2016). Chronic widespread musculoskeletal pain symptoms (>1 location using the Widespread Pain Index). High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months. If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment Over 18 and less than 65 years old (labour active). Ability to speak and understand English or Spanish. Exclusion Criteria: Acute or temporal pain Severe cognitive impairment, detected by the Mini-Mental State Examination (score <24 out of 30 points) Severe mental disorders in acute phase or symptomatic phase Behavioural alterations as this may interfere in their participation Severe intellectual disability Other severe or medically unstable diseases interfering with the project participation Co-occurrence of neuropathic pain Other disorders that may cause pain Pregnant or breast-feeding Drug abuse within the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nature-based stimulation program<br>Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation | Other: Nature-based sensory stimuli<br>* A program based on stimulation using nature-based sensory stimuli will be implemented<br>* Other names: Biogenic sensory stimuli;|
| Other: Control intervention<br>Participants will be involved in a placebo task for 30 minutes | Other: Control group intervention<br>* An activity based on a placebo intervention will be implemented<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10 | Change from baseline pain intensity after 30 minutes | 
| Cold pain thresholds | Cold pressor test will be used | Change from baseline cold pain thresholds after 30 minutes | 
| Punctate mechanical hyperalgesia | Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used | Change from baseline mechanical hyperalgesia after 30 minutes | 
| Wind-up phenomenon | Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception. | Change from baseline temporal summation of pain perception after 30 minutes | 
| Pressure pain thresholds | The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold | Change from baseline pressure pain thresholds after 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing