Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-10 @ 11:43 PM
Study NCT ID:
NCT06695351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain in Subjects with High Capacity Cognitive Abilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-16', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain', 'timeFrame': '1 day', 'description': 'The perceived pain intensity was evaluated using the visual analogue scale. This scale has shown good reliability and validity for the assessment of pain intensity.18 This measuring instrument evaluates the intensity of pain on a 10 cm line (0 being "no pain" and 10 being "the worst pain"). Participants were asked to make a mark on the line to represent the average intensity of the usual joint pain they endure in the last 30 days. Similarly, they were asked to mark the maximum degree of pain they report in the last month.'}], 'primaryOutcomes': [{'measure': 'Perceived quality of life', 'timeFrame': '1 day', 'description': 'Perceived quality of life was measured with the 36Item Short Form Health Survey (SF-36) scale validated in Spanish. This self-administered scale consists of 36 items in eight domains: physical functioning, limitations due to physical problems, physical pain, social role or function, mental health, limitations due to emotional problems, vitality and general perception of health.'}], 'secondaryOutcomes': [{'measure': 'Kinesiophobia', 'timeFrame': '1 day', 'description': "The Tampa Scale of Kinesiophobia (TSK-11) was used to assess patients' fear of moving or engaging in physical activity. We used the Spanish version of this self-administered instrument, which consists of 11 items rated on a 4-point Likert scale. The total score ranges from 11 to 44, with higher values corresponding to a greater fear of being injured again by the movement. Scores of more than 27 points are considered high. The minimum detectable change of this instrument is 5.6"}, {'measure': 'Catastrophising', 'timeFrame': '1 day', 'description': 'Catastrophism was assessed with the Pain Catastrophizing Scale. This scale is composed of 13 items rated on a scale from 0 to 4 points (a lower score indicates lower catastrophism). The questionnaire used is validated in Spanish'}, {'measure': 'Anxiety', 'timeFrame': '1 day', 'description': "Anxiety was evaluated with the validated Spanish version of the State-Trait Anxiety inventory (STAI) questionnaire. This measuring instrument has two self-assessment scales to measure two independent anxiety concepts: state and trait. Both scales have 20 items each, which are scored on a Likert scale having four possible replies (from 0 to 3). This questionnaire presents a good internal consistency in the Spanish version in anxiety/state (Cronbach's α = .90 - .93) and in anxiety/trait (Cronbach's α = .84 - .87)"}, {'measure': 'Physical activity', 'timeFrame': '1 day', 'description': "The instrument used to determine participants' PA level was the IPAQ short form. Total weekly amount of PA was calculated according to the method for computation of metabolic equivalent of task (MET)minutes/week, previously established in the IPAQ instructions for analysis and data processing of the questionnaire. Then, PA level was classified as: low (\\<600 METmin/week), moderate ( 600 METmin/week) and high ( 3000 METmin/week), following the same guidelines. This questionnaire has acceptable validity ( = 0.30, 95% CI: 0.23-0.36) and reliability (Spearman's =0.81, 95%CI:0.79-0.82) \\[30\\]. It has also been validated in Spain (r = 0.277; p \\< 0.05; 75% of specificity and sensibility; k = 0.33)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high cognitive abilities', 'Pain', 'Prevalence', 'Kinesiophobia', 'Catastrophising', 'giftedness'], 'conditions': ['High Cognitive Abilities', 'Pain', 'Prevalence']}, 'descriptionModule': {'briefSummary': 'In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. With this study the investigators will try to know better pain experience in this population and chronic pain prevalence', 'detailedDescription': "It's said that people with high cognitive abilities suffered pain. However, there are no scientific literature. With this study the investigators would like to know better pain experience in this population. There are two target groups include inside this population that we consider to study: Children population and adults population.\n\nThe aim of this study is to know the prevalence of chronic pain in this population and to analize the pain experience of this population and the related psychosocial variables that can modify it, like catastrophicing, kinesiophobia, anxiety, quality of life and level of physical activity,\n\nThe investigators will use a questionnaire that includes different questionnaires like TSK-11SV, PCS, STAI, SF-36 and IPAQ and many question to evaluate the demographic factor of the sample and the prevalence\n\nThe investigators will do an statistical analysis to observe the relationship and the predictors factors"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with a diagnosis of high cognitive abilities and spanish language', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* People with a diagnosis of high cognitive abilities\n\nExclusion Criteria:\n\n* People with incapacity to answer the questionnaire\n* People that's not have a good level of Spanish language"}, 'identificationModule': {'nctId': 'NCT06695351', 'briefTitle': 'Pain in Subjects with High Capacity Cognitive Abilities', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Pain in Subjects with High Capacity Cognitive Abilities: a Cross Sectional Study', 'orgStudyIdInfo': {'id': 'GIFTEDNESS_Pain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GIFTED', 'description': 'Patients with high cognitive abilities'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Villaviciosa de Odón', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Roberto Ucero-Lozano, PhD, PT, MSc, CHT', 'role': 'CONTACT', 'email': 'roberto.ucero@universidadeuropea.es', 'phone': '+34646466265'}, {'name': 'Rubén Cuesta-Barriuso, PhD, PT, MSc', 'role': 'CONTACT', 'email': 'cuestaruben@uniovi.es', 'phone': '+34 607547274'}, {'name': 'Roberto Ucero-Lozano, PhD, PT, MSc, CHT', 'role': 'CONTACT'}, {'name': 'Rubén Cuesta-Barriuso, PhD, PT, MSc', 'role': 'CONTACT'}, {'name': 'Alba Ortiz-Pérez', 'role': 'CONTACT'}], 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}], 'centralContacts': [{'name': 'Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT', 'role': 'CONTACT', 'email': 'roberto.ucero@universidadeuropea.es', 'phone': '+34 646466265'}, {'name': 'Rubén Cuesta-Barriuso, PhD, PT, MSc', 'role': 'CONTACT', 'email': 'cuesta.ruben@uniovi.es', 'phone': '+34607547274'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, PT, MSc, CHT', 'investigatorFullName': 'Roberto Ucero Lozano, PT, PhD', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}