Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06292793
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyclical Sighing for Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'immediately after the 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity Numeric Rating Scale', 'timeFrame': 'Immediately after the 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.'}, {'measure': 'Change in Anxiety Numeric Rating Scale', 'timeFrame': 'Immediately after the 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing intense anxiety.'}, {'measure': 'Change in Depression Numeric Rating Scale', 'timeFrame': 'Immediately after the 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 representing intense depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '39904867', 'type': 'DERIVED', 'citation': 'Hanley AW, Davis A, Worts P, Pratscher S. Cyclic sighing in the clinic waiting room may decrease pain: results from a pilot randomized controlled trial. J Behav Med. 2025 Apr;48(2):385-393. doi: 10.1007/s10865-024-00548-5. Epub 2025 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Seeking treatment at the Tallahassee Orthopedic Clinic\n\nExclusion Criteria:\n\n* Cognitive impairment preventing completion of study procedures.\n* Other unstable illness judged by medical staff to interfere with study involvement.'}, 'identificationModule': {'nctId': 'NCT06292793', 'briefTitle': 'Cyclical Sighing for Pain', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Cyclical Sighing for Pain in an Orthopedic Clinic Waiting Room', 'orgStudyIdInfo': {'id': 'STUDY00004696'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Coping Information', 'interventionNames': ['Behavioral: Pain Coping Information']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclical Sighing', 'interventionNames': ['Behavioral: Cyclical Sighing']}], 'interventions': [{'name': 'Pain Coping Information', 'type': 'BEHAVIORAL', 'description': 'A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).', 'armGroupLabels': ['Pain Coping Information']}, {'name': 'Cyclical Sighing', 'type': 'BEHAVIORAL', 'description': 'A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice.', 'armGroupLabels': ['Cyclical Sighing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Orthopedic Clinic (TOC)', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'Florida State University'}}}}