Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 11:26 AM
Study NCT ID:
NCT03348358
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2017-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Music on Stress and Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-25', 'studyFirstSubmitDate': '2017-10-01', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective stress', 'timeFrame': 'An hour after administration to delivery room', 'description': 'Stress as measured by saliva cortisol'}, {'measure': 'Subjective stress', 'timeFrame': 'An hour after administration to delivery room', 'description': 'Stress as measured by questionnaires'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Cesarean delivery/ vaginal delivery/ operative delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Delivery Problem for Fetus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes', 'detailedDescription': 'For centuries, music has been known to have therapeutic effects on the body and the mind A large body of findings is related to the therapeutic potential of music in clinical settings, mainly among patients undergoing surgical and dental procedures, and also in other medical environments, such as intensive care, psychiatry, and geriatrics. Using music interventions in clinical settings was associated with reductions in negative effects in addition to objective stress and anxiety indices such as reduced heart rate, blood pressure, myocardial oxygen consumption, gastrointestinal function, anxiety, pain, and increased oxytocin levels.\n\nOne study found that women who listened to music before a cesarean section had a significant increase in positive emotions and a significant reduction in systolic blood pressure compared with a significant increase in diastolic blood pressure and respiratory rate in the control group. Li and Dong concluded in a different study, that preoperative music intervention can reduce anxiety and pain in women undergoing cesarean delivery.\n\nVarious studies examined the relation of music during labor to pain relief. One study found that the group of women going through music therapy had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labor. One randomly assigned study found that women listened to soft music starting early in the active phase of labor had decreased sensation and distress of active labor pain. To date, no study examined the level of salivary cortisol while music is played at delivery room as an objective estimation of the stress level.\n\nIn addition to that, there is a lack of information regarding the effect of music during labor on the obstetric and perinatal outcomes.\n\nTherefore, the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaire, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-45\n* single embryo\n* term labor, \\>=37 weeks of gestation\n\nExclusion Criteria:\n\n* multiple embryos\n* Antepartum fetal death\n* preterm delivery'}, 'identificationModule': {'nctId': 'NCT03348358', 'briefTitle': 'Effect of Music on Stress and Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?', 'orgStudyIdInfo': {'id': 'Music in delivery room'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'No music during labor', 'interventionNames': ['Behavioral: control']}, {'type': 'EXPERIMENTAL', 'label': 'Quiet music', 'description': 'Women hearing quiet music during labor', 'interventionNames': ['Behavioral: quiet music']}, {'type': 'EXPERIMENTAL', 'label': 'Rhythmic music', 'description': 'Women hearing rhythmic music during labor', 'interventionNames': ['Behavioral: Rhythmic music']}], 'interventions': [{'name': 'quiet music', 'type': 'BEHAVIORAL', 'description': 'playing quiet music during labor', 'armGroupLabels': ['Quiet music']}, {'name': 'Rhythmic music', 'type': 'BEHAVIORAL', 'description': 'playing rhythmic music during labor', 'armGroupLabels': ['Rhythmic music']}, {'name': 'control', 'type': 'BEHAVIORAL', 'description': 'No music during labor', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yael Pasternak, MD', 'role': 'CONTACT', 'email': 'yaeli.pasternak@gmail.com', 'phone': '+972525517521'}], 'facility': 'Meir Medical center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yael Pasternak', 'investigatorAffiliation': 'Meir Medical Center'}}}}