Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT05017220
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2021-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nature-based Sensory Stimulation on Pain Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Change from baseline pain intensity after 30 minutes', 'description': 'Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10'}, {'measure': 'Cold pain thresholds', 'timeFrame': 'Change from baseline cold pain thresholds after 30 minutes', 'description': 'Cold pressor test will be used'}, {'measure': 'Punctate mechanical hyperalgesia', 'timeFrame': 'Change from baseline mechanical hyperalgesia after 30 minutes', 'description': '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'}, {'measure': 'Wind-up phenomenon', 'timeFrame': 'Change from baseline temporal summation of pain perception after 30 minutes', 'description': '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.'}, {'measure': 'Pressure pain thresholds', 'timeFrame': 'Change from baseline pressure pain thresholds after 30 minutes', 'description': 'The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Nature-based activities', 'Pain dimensions', 'Multisensory stimulation', 'Quantitative sensory testing'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of fibromyalgia syndrome (ACR criteria 2016).\n* Chronic widespread musculoskeletal pain symptoms (\\>1 location using the Widespread Pain Index).\n* High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.\n* If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment\n* Over 18 and less than 65 years old (labour active).\n* Ability to speak and understand English or Spanish.\n\nExclusion Criteria:\n\n* Acute or temporal pain\n* Severe cognitive impairment, detected by the Mini-Mental State Examination (score \\<24 out of 30 points)\n* Severe mental disorders in acute phase or symptomatic phase\n* Behavioural alterations as this may interfere in their participation\n* Severe intellectual disability\n* Other severe or medically unstable diseases interfering with the project participation\n* Co-occurrence of neuropathic pain\n* Other disorders that may cause pain\n* Pregnant or breast-feeding\n* Drug abuse within the past year.'}, 'identificationModule': {'nctId': 'NCT05017220', 'briefTitle': 'Nature-based Sensory Stimulation on Pain Levels', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'NBS in chronic pain patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nature-based stimulation program', 'description': 'Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation', 'interventionNames': ['Other: Nature-based sensory stimuli']}, {'type': 'OTHER', 'label': 'Control intervention', 'description': 'Participants will be involved in a placebo task for 30 minutes', 'interventionNames': ['Other: Control group intervention']}], 'interventions': [{'name': 'Nature-based sensory stimuli', 'type': 'OTHER', 'otherNames': ['Biogenic sensory stimuli'], 'description': 'A program based on stimulation using nature-based sensory stimuli will be implemented', 'armGroupLabels': ['Nature-based stimulation program']}, {'name': 'Control group intervention', 'type': 'OTHER', 'description': 'An activity based on a placebo intervention will be implemented', 'armGroupLabels': ['Control intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18008', 'city': 'Granada', 'country': 'Spain', 'facility': 'Faculty of Health Sciences', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '18008', 'city': 'Granada', 'country': 'Spain', 'facility': 'Universidad de Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator / Associate professor', 'investigatorFullName': 'José Manuel Pérez Mármol', 'investigatorAffiliation': 'Universidad de Granada'}}}}