Nature-based Sensory Stimulation on Pain Levels

University of Granada (UGR)

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Nature-based sensory stimuli

Other: Control group intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05017220

NBS in chronic pain patients

Details and patient eligibility

About

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

Full description

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.

Enrollment

42 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.