Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT04762004
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The pain score was assessed by two blinded independent and trained coders on muted video tracks. Oxytocin analysis were performed by an external Lab, blinded to the conditions.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover clinical trial with a repeated measures design. Each patient is assigned to a sequence of three treatments (maternal speech, maternal singing, and standard treatment).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'Immediately after the procedure', 'description': 'The PIPP-R score is a cluster of physiological and behavioural measures. Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher. Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores. Higher levels of pain scores indicate higher levels of pain'}, {'measure': 'oxytocin levels', 'timeFrame': 'Pre procedure', 'description': 'Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.'}, {'measure': 'oxytocin levels', 'timeFrame': 'Immediately after the procedure', 'description': 'Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxytocin', 'Maternal voice', 'Neonatal Intensive Care Unit'], 'conditions': ['Preterm Birth', 'Pain, Procedural']}, 'descriptionModule': {'briefSummary': "Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.", 'detailedDescription': "Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.\n\nThe aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.\n\nIn the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>29 weeks gestational age at birth,\n* weight \\>1000 g\n* stable medical condition (absence of mechanical ventilation, no additional oxygen)\n\nExclusion Criteria:\n\nFor infants\n\n* no specific pathological conditions\n* no genetic abnormalities\n\nFor mothers\n\n* history of substance abuse\n* mental health problems'}, 'identificationModule': {'nctId': 'NCT04762004', 'briefTitle': 'Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures', 'orgStudyIdInfo': {'id': '90.513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maternal speech', 'description': 'During the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.', 'interventionNames': ['Behavioral: Maternal speech']}, {'type': 'EXPERIMENTAL', 'label': 'Maternal singing', 'description': 'During the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.', 'interventionNames': ['Behavioral: Maternal singing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'During the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'Maternal speech', 'type': 'BEHAVIORAL', 'description': 'In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.', 'armGroupLabels': ['Maternal speech']}, {'name': 'Maternal singing', 'type': 'BEHAVIORAL', 'description': 'In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.', 'armGroupLabels': ['Maternal singing']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Didier M Grandjean, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manuela Filippa', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}