Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT07107360
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pain Neuroscience Education on Preoperative Anxiety and Postoperative Recovery in Patients Scheduled for Orthopedic Surgery
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain-related beliefs', 'timeFrame': 'Assessments were performed at two time points: one hour prior to surgery and one month after surgery.', 'description': 'Pain Catastrophizing: The Pain Catastrophizing Scale (PCS) was developed in 1995 by Michael J. L. Sullivan and colleagues (Sullivan et al., 1995). The PCS is a 13-item self-report measure that assesses the extent of catastrophizing in the context of actual or anticipated pain. It conceptualizes catastrophizing as a multidimensional construct, measured across three subscales: rumination, magnification, and helplessness. Rumination refers to the tendency to focus on pain-related thoughts, helplessness reflects a perceived inability to cope with painful situations, and magnification represents an exaggerated interpretation of the threat value of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain neuroscience education', 'preoperative anxiety', 'recovery', 'orthopaedic surgery'], 'conditions': ['Orthopaedic Surgery', 'Upper Extremity']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effects of preoperative PNE on preoperative anxiety, pain-related beliefs, and postoperative functional outcomes in patients undergoing upper extremity orthopedic surgery.', 'detailedDescription': 'This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. The study was completed with a total of 33 participants aged between 18 and 65 years who were scheduled for upper extremity surgery. Participants were randomly assigned to either the pain neuroscience education group or the control group.\n\nThe inclusion criteria were as follows: aged between 18 and 65 years; scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently, understands verbal and written instructions, and has no speech impairments); and willing to voluntarily participate in the study.\n\nParticipants were excluded from the study if they met any of the following conditions: mental or cognitive impairments; are currently using medication for anxiety or related conditions; taking painkillers regularly; or have undergone any surgical procedures within the past year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 and 65 years\n* scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently,\n* understands verbal and written instructions, and has no speech impairments);\n* willing to voluntarily participate in the study.\n\nExclusion Criteria:\n\n* any mental or cognitive impairments\n* currently using medication for anxiety or related conditions\n* taking painkillers regularly\n* have undergone any surgical procedures within the past year.'}, 'identificationModule': {'nctId': 'NCT07107360', 'briefTitle': 'The Effect of Pain Neuroscience Education on Preoperative Anxiety and Postoperative Recovery in Patients Scheduled for Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Pain Neuroscience Education for Patients Undergoing Orthopaedic Surgery: Exploring Preoperative Anxiety and Improving Postoperative Recovery', 'orgStudyIdInfo': {'id': 'Pain Neuroscience Education'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Neuroscience Education Group', 'description': 'received pain neuroscience education in addition to conventional preoperative education', 'interventionNames': ['Other: Pain Neuroscience Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'received conventional preoperative education', 'interventionNames': ['Other: Conventional preoperative education']}], 'interventions': [{'name': 'Pain Neuroscience Education', 'type': 'OTHER', 'description': 'The study included two groups, consisting of participants who met the inclusion criteria and adhered to the procedures. Participants in the intervention group received a 20-minute Pain Neuroscience Education (PNE) session delivered face-to-face one hour prior to their scheduled surgery. The PNE focused on the biopsychosocial aspects of pain and included both theoretical and practical strategies for postoperative pain management.', 'armGroupLabels': ['Pain Neuroscience Education Group']}, {'name': 'Conventional preoperative education', 'type': 'OTHER', 'description': 'Participants in the experimental group received pain neuroscience education, while participants in the control group received a booklet summarizing this education in addition to routine preoperative care.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34413', 'city': 'Istanbul', 'state': 'Kagıthane', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'asst. prof.', 'investigatorFullName': 'SOzkan', 'investigatorAffiliation': 'Atlas University'}}}}