Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 6:16 AM
Study NCT ID:
NCT06969105
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Use in Parturients Admitted to Labor & Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-13', 'size': 338002, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-15T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group will listen to music (intervention) and the other group will not listen to music (control).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline and 0 hours post-intervention', 'description': 'Anxiety will be assessed in two ways. The first using a 0-10 numeric rating scale in which subjects rate their self-perceived anxiety level on this scale. Secondly, they will answer survey questions on the State-Trait Anxiety Inventory questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': 'Baseline to 0 hours post-intervention', 'description': 'Pain will be assessed on a 0-10 numeric rating scale in which subjects rate their self-perceived level of pain.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '0 hours post-intervention', 'description': 'Patient satisfaction will be assessed using a survey question asking how satisfied the patient is with their care. Subject will rate their satisfaction level as very poor, somewhat poor, average, satisfied, or very satisfied.'}, {'measure': 'Anxiety', 'timeFrame': 'Request of labor analgesia and 0,1 hour post-epidural catheter placement', 'description': 'Anxiety levels will be assessed using a 0-10 numerical rating scale and on the State Trait Anxiety Inventory questionnaire. Subject will rate their self-perceived anxiety level and answer survey questions.'}, {'measure': 'Pain Level', 'timeFrame': 'Request of labor analgesia and 0,1 hours post-epidural catheter placement', 'description': 'Pain will be assessed using a 0-10 numerical rating scale. Subject will rate their self-perceived pain level on this scale.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Request of labor analgesia and 0,1 hours post-epidural catheter placement', 'description': 'Blood pressure will be recorded in units of millimeters of mercury (mmHg) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}, {'measure': 'Heart Rate', 'timeFrame': 'Request of labor analgesia and 0,1 hours post-epidural catheter placement', 'description': 'Heart rate will be recorded in units of beats per minute (bpm) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Request of labor analgesia and 0,1 hours post-epidural catheter placement', 'description': 'Oxygen saturation will be recorded as a percentage (SpO2) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline to 0 hours post-intervention', 'description': 'Blood pressure will be recorded in units of millimeters of mercury (mmHg) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Baseline to 0 hours post-intervention', 'description': 'Oxygen saturation will be recorded as a percentage (SpO2) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline to 0 hours post-intervention', 'description': 'Heart rate will be recorded in units of beats per minute (bpm) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music', 'labor and delivery', 'parturients', 'anxiety', 'analgesia', 'anesthesia', 'pain', 'epidural'], 'conditions': ['Anxiety', 'Pain', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '20642059', 'type': 'BACKGROUND', 'citation': 'Tabarro CS, de Campos LB, Galli NO, Novo NF, Pereira VM. [Effect of the music in labor and newborn]. Rev Esc Enferm USP. 2010 Jun;44(2):445-52. doi: 10.1590/s0080-62342010000200029. Portuguese.'}, {'pmid': '12836149', 'type': 'BACKGROUND', 'citation': 'Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.'}, {'pmid': '25227477', 'type': 'BACKGROUND', 'citation': 'Simavli S, Gumus I, Kaygusuz I, Yildirim M, Usluogullari B, Kafali H. Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: a randomized controlled clinical trial. Gynecol Obstet Invest. 2014;78(4):244-50. doi: 10.1159/000365085. Epub 2014 Sep 16.'}, {'pmid': '33050409', 'type': 'BACKGROUND', 'citation': 'Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526.'}, {'pmid': '20492051', 'type': 'BACKGROUND', 'citation': 'Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.'}, {'pmid': '9710387', 'type': 'BACKGROUND', 'citation': 'Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. doi: 10.1097/00000542-199808000-00005.'}, {'pmid': '23894767', 'type': 'BACKGROUND', 'citation': 'Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.'}, {'pmid': '40019185', 'type': 'BACKGROUND', 'citation': 'Fong TM, Drzymalski DM. The 95% Effective Duration of Music for Anxiolysis Before Elective Cesarean Delivery. A A Pract. 2025 Feb 28;19(3):e01931. doi: 10.1213/XAA.0000000000001931. eCollection 2025 Mar 1.'}, {'pmid': '27984250', 'type': 'BACKGROUND', 'citation': 'Drzymalski DM, Tsen LC, Palanisamy A, Zhou J, Huang CC, Kodali BS. A Randomized Controlled Trial of Music Use During Epidural Catheter Placement on Laboring Parturient Anxiety, Pain, and Satisfaction. Anesth Analg. 2017 Feb;124(2):542-547. doi: 10.1213/ANE.0000000000001656.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. The main questions it aims to answer are:\n\nDoes music use affect anxiety levels in parturients admitted to labor and delivery? Does music use affect pain levels in parturients admitted to labor and delivery? Does music use affect patient satisfaction in parturients admitted to labor and delivery?\n\nResearchers will compare music to a control (no music) to see if music affects anxiety levels in parturients admitted to labor and delivery.\n\nParticipants will:\n\nListen to music or listen to no music for a 10 minute duration in the labor and delivery unit.\n\nAnswer questions about anxiety and pain levels at a few different timepoints. Have information collected from medical charts (vital signs and cervical dilation).\n\nRate their satisfaction with care.', 'detailedDescription': "Subjects will be asked their preferred music choice before they are randomly assigned to either the intervention music group, or the no music control group.\n\nThe study's active intervention group will be listening to the subject's preferred music for a duration of 10 minutes. The subjects will listen to their preferred music choice played from a speaker connected to an audio device, both supplied by the research team. The investigator and the patient will collaborate on patient positioning of the audio device for sound to optimize comfort and safety during the study intervention. Researchers will confirm the volume of the music and assess subject's comfort before leaving the room for 10 minutes while they listen to music. Subjects must turn off all other noises such as television, other music being played, phone calls ringer/vibration, and texting notifications will be turned off prior to initiation of the study. Phone calls and texting may be left on for subject's who request this. The study team will wait outside the door for 10 minutes, before re-entering. Nursing and providers essential to care will be notified that the subject is participating in the study to ensure no one enters the room unless medically necessary or in case of emergency during this 10-minute time period.\n\nThe Control group will not listen to music. The study team will still leave the room for 10 minutes and then re-enter to continue collecting data at each of the time points as below:\n\nBefore the intervention begins, researchers will collect from all parturient subjects' their anxiety score (on a scale of 0-10, with 0 being no anxiety), ask them to complete the STAI questionnaires on paper to collect their scores (submitted) and pain score, and record the time data was collected. Researchers will also record clinical data from the EMR for the parturient subject or ask the nurses for the data at the time they take these readings (see Data Collection Form).\n\nIf parturient subjects request labor analgesia and have an epidural catheter placed, researchers will collect the same data from parturient subjects both at the time that the request is made and within 30 minutes of the catheter being placed. The data collected from these two timepoints is an optional component of the study (see Informed Consent Form). The subjects can consent ahead of time in the ICF but may withdraw consent for these 2 data points and still be in the rest of the study as the data collected at these 2 timepoints are secondary objectives to explore. If a member of the research team is not in the room at the time this happens, researchers will not collect Anxiety, STAI or pain score and will only collect what is available from the charts, as per the Data Collection Form.\n\nAfter the intervention (or time has passed, if they are in the control group), the same information will be collected from all participants a second time (see Data Collection Form). Parturient satisfaction will be recorded (Data Collection Form). Nurses on the subject's normal care team will be asked to assist with collecting the vitals for the data collection forms.\n\nAll procedures are occurring for research purposes only. Initial vitals collected will be done as per standard care and data will only be pulled later from charts or researchers will ask the nurses for the information as they are collecting it. Later vitals collected, if done at a time where they are not being collected for standard care, will be collected for research only - by the standard care team nurses."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years or older\n* Laboring parturients or those scheduled for an induction of labor\n* Able to provide informed consent\n* American Society of Anesthesiologists (ASA) physical status rating of II-III\n\nExclusion Criteria:\n\n* Patient refusal\n* Impaired hearing\n* Patient is taking at least one anxiolytic medication daily at baseline\n* Intrauterine fetal demise\n* Severe psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT06969105', 'briefTitle': 'Music Use in Parturients Admitted to Labor & Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial of Music Use in Parturients Admitted to Labor & Delivery', 'orgStudyIdInfo': {'id': 'STUDY00005897'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Group', 'description': 'Subjects randomized to this arm will listen to music for a 10 minute duration.', 'interventionNames': ['Other: Music']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Subjects randomized to this arm will not listen to music for a 10 minute duration.'}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'description': 'Prior to randomization, all participants will pre-select their preferred music genre. If randomized to the music group, their preferred music genre will be played for a 10 minute duration.', 'armGroupLabels': ['Music Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Drzymalski, Medical Doctor', 'role': 'CONTACT', 'email': 'ddrzymalski@tuftsmedicalcenter.org', 'phone': '617-913-8168'}], 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Sophia Struzziero, Medical Student', 'role': 'CONTACT', 'email': 'sophia.struzziero@tufts.edu', 'phone': '6178331209'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}