Nature-based Sensory Stimulation on Pain Levels

NCT ID: NCT05017220

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-08-31

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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Nature-based stimulation program

Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation

Group Type EXPERIMENTAL

Nature-based sensory stimuli

Intervention Type OTHER

A program based on stimulation using nature-based sensory stimuli will be implemented

Control intervention

Participants will be involved in a placebo task for 30 minutes

Group Type OTHER

Control group intervention

Intervention Type OTHER

An activity based on a placebo intervention will be implemented

Interventions

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Nature-based sensory stimuli

A program based on stimulation using nature-based sensory stimuli will be implemented

Intervention Type OTHER

Control group intervention

An activity based on a placebo intervention will be implemented

Intervention Type OTHER

Other Intervention Names

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Biogenic sensory stimuli

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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José Manuel Pérez Mármol

Principal Investigator / Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Health Sciences

Granada, , Spain

Site Status

Universidad de Granada

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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NBS in chronic pain patients

Identifier Type: -

Identifier Source: org_study_id

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