Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:33 PM
Study NCT ID:
NCT07437469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Binaural Beats for Postoperative Pain and Anxiety Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline (pre-operative) to 4 hours post-operation.', 'description': 'Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Change will be calculated as the difference between the pre-operative NPRS score and the NPRS score obtained 4 hours after surgery. Higher scores indicate greater pain intensity.'}, {'measure': 'Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)', 'timeFrame': 'Baseline (pre-operative) to 4 hours post-operation.', 'description': 'Anxiety will be measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, producing a total score range of 20-80, with higher scores indicating greater state anxiety. Change will be calculated as the difference between the pre-operative STAI-S score and the STAI-S score obtained 4 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)', 'timeFrame': 'From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)', 'description': 'Total opioid use administered during the post-anesthesia care unit (PACU) stay will be recorded, including all intravenous and oral opioid medications. All doses will be converted to morphine milligram equivalents (MME) using standard Centers for Disease Control and Prevention (CDC) conversion factors. Unit of Measure: Morphine milligram equivalents (MME)'}, {'measure': 'Postoperative Vital Signs Heart Rate', 'timeFrame': 'Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).', 'description': 'Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': 'Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation', 'description': 'Patient satisfaction with the postoperative experience will be measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. Unit of Measure: Likert score (1-5)'}, {'measure': 'Postoperative Vital Signs Blood Pressure', 'timeFrame': 'Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).', 'description': 'Systolic and diastolic blood pressure (millimeters of mercury) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.'}, {'measure': 'Postoperative Vital Signs Respiratory Rate', 'timeFrame': 'Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).', 'description': 'Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['THA', 'TKA', 'Total hip arthroplasty', 'Total knee arthroplasty', 'Anxiety', 'Pain', 'Binaural Beats', 'Music Exposure'], 'conditions': ['TKA', 'THA', 'Anxiety', 'Binaural Beats', 'Music Exposure', 'Total Hip Arthroplasty (THA)', 'Total Knee Arthroplasty', 'Total Knee Replacement', 'Total Hip Replacement']}, 'descriptionModule': {'briefSummary': 'To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3\n* Spinal anesthesia\n* Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)\n* Primary total hip or total knee arthroplasty\n\nExclusion Criteria:\n\n* Moderate-severe hearing impairment or use of hearing aids\n* History of significant tinnitus, active delirium, chronic high-dose opioid therapy (\\>60 MME/day baseline)\n* Major psychiatric pathology\n* General anesthesia'}, 'identificationModule': {'nctId': 'NCT07437469', 'briefTitle': 'Binaural Beats for Postoperative Pain and Anxiety Reduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20251389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Binaural Beats (BB)', 'description': 'Participants assigned to this arm will listen to a 30-minute binaural beats audio session at a comfortable volume through standardized over-ear headphones while in the post-anesthesia care unit (PACU). The audio will use a primary target frequency of 10 Hz (alpha range), created using soft sine-wave carriers in the 200-600 Hz range that generate a 10 Hz interaural difference (e.g., 400 Hz left ear / 410 Hz right ear). Volume will be set at a comfortable conversational level (\\~55-65 dBA) and may be adjusted by the participant. The session will begin within 15 minutes of PACU arrival. Participants may stop the audio at any time.', 'interventionNames': ['Other: Binaural Beats Audio Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music of Choice (MOC)', 'description': 'Participants in this arm will receive usual postoperative care in the post-anesthesia care unit (PACU) and may listen to music of their choice using standardized headphones. They will select their preferred music and listen for 30 minutes at a comfortable volume (\\~55-65 dBA), which they may adjust as needed. No binaural beat frequencies will be used. Music listening is optional and may be stopped at any time.', 'interventionNames': ['Other: Music of Choice']}], 'interventions': [{'name': 'Binaural Beats Audio Intervention', 'type': 'OTHER', 'description': '30-minute binaural beats audio session targeting 400 and 410 hertz (Hz) alpha 400 hertz (Hz) in one ear 410 hertz (Hz) in other ear frequency delivered through standardized headphones in the PACU.', 'armGroupLabels': ['Binaural Beats (BB)']}, {'name': 'Music of Choice', 'type': 'OTHER', 'description': 'Usual postoperative care in addition to patient-selected music using standardized headphones', 'armGroupLabels': ['Music of Choice (MOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33132', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Andrew R Moya, MD', 'role': 'CONTACT', 'email': 'arm577@miami.edu', 'phone': '786-856-6463'}, {'name': 'Victor H Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univeristy of Miami Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Andrew R Moya, MD', 'role': 'CONTACT', 'email': 'arm577@miami.edu, doc.a.moya1@gmail.com', 'phone': '1786-856-6463'}], 'overallOfficials': [{'name': 'Victor H Hernandez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Joint Replacement', 'investigatorFullName': 'Victor Hugo Hernandez', 'investigatorAffiliation': 'University of Miami'}}}}