Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT06287359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual interviews', 'timeFrame': 'baseline', 'description': 'To understand the lived experience of parents/carers during the daily care of their child by means of a phenomenological analysis of the interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.\n\nFor patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.\n\nThe investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.\n\nTo achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.\n\nWith this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Parents or carers of children with severe motor disabilities complaining of spinal pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents or carers of children with severe motor disabilities complaining of spinal pain\n\nExclusion Criteria:\n\n* Parent/carer refusing to participate'}, 'identificationModule': {'nctId': 'NCT06287359', 'acronym': 'Vé-Quo-Pa-H-R', 'briefTitle': 'Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'What is the Day-to-day Experience of Parents/Carers of Children or Adolescents With Severe Motor Disabilities Suffering From Spinal Pain?', 'orgStudyIdInfo': {'id': 'Local/2024/MP-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents/carers', 'description': 'Parents or carers of children with severe motor disabilities complaining of spinal pain', 'interventionNames': ['Other: individual interviews']}], 'interventions': [{'name': 'individual interviews', 'type': 'OTHER', 'description': 'Qualitative research with individual interviews', 'armGroupLabels': ['Parents/carers']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mélanie PORTE', 'role': 'CONTACT', 'email': 'melanie.porte@chu-nimes.fr', 'phone': '+33 4 66 68 34 59'}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}