Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:56 AM
Study NCT ID:
NCT07335159
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Interest in additional pain management resources', 'timeFrame': 'Immediately after the 4-minute audio recording', 'description': 'After the recording, participants will complete a single dichotomous (yes/no) item assessing interest in additional pain management resources: "Would you like access to additional pain management resources similar to the one presented today?"'}, {'measure': 'Net Promoter Scale', 'timeFrame': 'Immediately after the 4-minute audio recording', 'description': 'The Net Promoter Scale (NPS) is a single-item measure of satisfaction and loyalty that asks respondents to rate how likely they are to recommend a product, service, or experience to others, typically on an 11-point scale from 0 ("not at all likely") to 10 ("extremely likely"). Responses are categorized as detractors (0-6), passives (7-8), or promoters (9-10). The overall NPS score is calculated by subtracting the percentage of detractors from the percentage of promoters, yielding a score ranging from -100 to +100.'}], 'primaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'Immediately before to after 4-minute audio recording', 'description': 'Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity Numeric Rating Scale', 'timeFrame': 'Immediately before to after 4-minute audio recording', 'description': 'Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Acute Pain', 'Chronic Pain', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'This project is a single-site, two-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room an audio-recorded mindfulness practice decreases their pain relative to an injury management control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving treatment at Tallahassee Orthopedic Center\n* Understanding English instructions fluently\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Unable to consent because of physical or mental incapacity.'}, 'identificationModule': {'nctId': 'NCT07335159', 'briefTitle': 'Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Does Patient Testimonial Improve the Pain Relief Derived From a Brief Behavioral Intervention Delivered to Patients Experiencing Pain in a Clinic Waiting Room', 'orgStudyIdInfo': {'id': 'STUDY00004916_Testimonial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Psychoeducation', 'description': 'In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.', 'interventionNames': ['Behavioral: Pain Psychoeducation']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'In the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.', 'interventionNames': ['Behavioral: Mindfulness']}], 'interventions': [{'name': 'Pain Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.', 'armGroupLabels': ['Pain Psychoeducation']}, {'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'In the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.', 'armGroupLabels': ['Mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emilie Miley', 'role': 'CONTACT', 'email': 'Emilie.Miley@teamtoc.com', 'phone': '850-877-8174'}], 'facility': 'Tallahassee Orthopedic Clinic', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'centralContacts': [{'name': 'Adam Hanley', 'role': 'CONTACT', 'email': 'adam.hanley@fsu.edu', 'phone': '850-645-9557'}, {'name': 'Carter Minnick', 'role': 'CONTACT', 'email': 'cm25bo@fsu.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'Florida State University'}}}}