Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-30 @ 5:26 AM
Study NCT ID:
NCT06909461
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2025-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pain Neuroscience Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain neurophysiology knowledge', 'timeFrame': 'an hour', 'description': 'The 12-item Revised Neurophysiology of Pain Questionnaire (RNP-Q) will be used to assess pain neurophysiology knowledge. Responses will be marked yes, no or undecided. One point is awarded for correct answers. Scores range from 0 to 12, with high scores indicating good knowledge. The RNPQ is a valid and reliable tool for assessing pain neurophysiology knowledge.'}], 'secondaryOutcomes': [{'measure': 'Attitudes and behaviours', 'timeFrame': 'an hour', 'description': "The modified Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) will be used to assess students' attitudes and behaviours. This 13-item questionnaire uses a 7-point Likert scale (strongly disagree to strongly agree). Scores range from 13 to 91 with lower scores suggesting more positive attitudes. The HC-PAIRS has demonstrated good levels of validity and reliability."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Student Education']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of pain neuroscience education (PNE) on physiotherapy students\' knowledge, attitudes and behaviors towards pain. A total of 52 physiotherapy students will be included in the study. Students will be randomly randomly assigned to either PNE group (n=26) or control group (CG) (n=26). The PNE group will be receive a 70-min PNE based on the explanations used in "Explain Pain". The CG group will be received an education about red-flags which are special screening questions for serious pathology. The red-flags education will be discussed tissue pathology and Waddell\'s triage for back pain classification.Neurophysiology and the biopsychosocial model will not be discussed. Before, immediately after, and 2-months after the education sessions all students will be completed four questionnaires, the Revised Neurophysiology Pain Questionnaire (RNP-Q), the Health Care Providers\' Pain and Impairment Relationship Scale(HC-PAIRS), and the red-flags questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteer to participate in study\n* to studying in physiotherapy\n* be able to read and understand Turkish\n\nExclusion Criteria:\n\n\\- having received pain neuroscience education'}, 'identificationModule': {'nctId': 'NCT06909461', 'briefTitle': 'The Effect of Pain Neuroscience Education', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': "The Effect of Pain Neuroscience Education on Physiotherapy Students' Knowledge, Attitudes and Behaviours Towards Pain: A Single-blinded Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'CBU-FTR-ES-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Neuroscience Education Group', 'description': 'The pain neuroscience education group will be receive a 70-min pain neuroscience education.', 'interventionNames': ['Other: Pain neuroscience education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Red-flags education The control group will be receive a 70-min red-flags education.', 'interventionNames': ['Other: Red-flags education']}], 'interventions': [{'name': 'Pain neuroscience education', 'type': 'OTHER', 'description': 'The pain neuroscience education group will be receive a 70-min pain neuroscience education.', 'armGroupLabels': ['Pain Neuroscience Education Group']}, {'name': 'Red-flags education', 'type': 'OTHER', 'description': 'The control group will be receive a 70-min red-flags education.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manisa', 'state': 'Mani̇sa', 'country': 'Turkey (Türkiye)', 'facility': 'Manisa Celal Bayar University', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erhan Seçer', 'investigatorAffiliation': 'Celal Bayar University'}}}}