Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 9:27 PM
Study NCT ID:
NCT05030233
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Nursing Touch and Biobehavioral Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], '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': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nist.10@osu.edu', 'phone': '614-247-5781', 'title': 'Marliese D. Nist', 'organization': 'The Ohio State University College of Nursing'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Essential nursing care is scheduled to occur every 3 hours in the NICU. Study electrodes were attached to enrolled infants during the caregiving episode preceding the observed caregiving episode during which data collection occurred. Adverse events were documented from the time study electrodes were attached to the infant until the end of the 30-minute recovery period following the observed caregiving episode. Thus, total recording of adverse events was approximately 3.5 hours.', 'description': 'standard definition applied', 'eventGroups': [{'id': 'EG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 5, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'bradycardia or oxygen desaturation', 'notes': 'episode of bradycardia with heart rate \\<100 beats per minute for 10 seconds and/or oxygen desaturation with SpO2 \\<85% for 10 seconds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Heart Rate -- During Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '172.6', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '168.6', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during intervention or control period, approximately 20 minutes', 'description': 'heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 enrolled infants in randomized cross-over trial'}, {'type': 'PRIMARY', 'title': 'Average Heart Rate -- Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '161.7', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '158.6', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'recovery, 30 minutes after intervention delivery or control period', 'description': 'heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 total infants participated in randomized cross-over trial'}, {'type': 'SECONDARY', 'title': 'Average High-frequency Heart Rate Variability -- During Caregiving Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.8'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes', 'description': 'Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.', 'unitOfMeasure': 'ln(ms^2)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '19 total participants in randomized cross-over trial'}, {'type': 'SECONDARY', 'title': 'Average High-frequency Heart Rate Variability -- Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care', 'description': 'Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.', 'unitOfMeasure': 'ln(ms^2)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '19 total participants in randomized cross-over trial'}, {'type': 'SECONDARY', 'title': 'Average Frequency of Skin Conductance Responses -- During Caregiving Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during caregiving episode, approximately 20 minutes', 'description': "Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving.", 'unitOfMeasure': 'waves per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 total participants in randomized cross-over trial'}, {'type': 'SECONDARY', 'title': 'Average Frequency of Skin Conductance Responses -- Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'recovery, 30 minutes after intervention delivery or control period', 'description': "Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period.", 'unitOfMeasure': 'waves per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 total participants in randomized cross-over trial'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Nurse-Administered Touch Intervention, Then Standard Care', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.\n\nStandard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine."}, {'id': 'FG001', 'title': 'Experimental: Standard Care, Then Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care that includes the nurse-administered touch intervention.\n\nStandard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'withdrawn for transfer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Nurse-Administered Touch Intervention, Then Standard Care', 'description': "Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.\n\nStandard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine."}, {'id': 'BG001', 'title': 'Experimental: Standard Care, Then Nurse-Administered Touch Intervention', 'description': "Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive an episode of essential nursing care that includes the nurse-administered touch intervention.\n\nStandard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.\n\nNurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'groupId': 'BG000', 'lowerLimit': '27.3', 'upperLimit': '30.7'}, {'value': '28.7', 'groupId': 'BG001', 'lowerLimit': '27.1', 'upperLimit': '30.4'}, {'value': '28.8', 'groupId': 'BG002', 'lowerLimit': '27.1', 'upperLimit': '30.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks gestation at birth', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birthweight', 'classes': [{'categories': [{'measurements': [{'value': '1339', 'groupId': 'BG000', 'lowerLimit': '920', 'upperLimit': '1967'}, {'value': '1158.4', 'groupId': 'BG001', 'lowerLimit': '870', 'upperLimit': '1510'}, {'value': '1253.5', 'groupId': 'BG002', 'lowerLimit': '870', 'upperLimit': '1967'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': '10 infants assigned to receive nurse-administered touch intervention followed by standard care sequence; 9 infants assigned to receive standard care followed by nurse-administered touch intervention sequence'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-08', 'size': 505016, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-12T14:45', 'hasProtocol': True}, {'date': '2021-11-08', 'size': 322809, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-12T15:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The statistician performing the data analysis will be blinded to group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized cross-over design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2021-08-23', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-30', 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Heart Rate -- During Intervention', 'timeFrame': 'during intervention or control period, approximately 20 minutes', 'description': 'heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period'}, {'measure': 'Average Heart Rate -- Recovery', 'timeFrame': 'recovery, 30 minutes after intervention delivery or control period', 'description': 'heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period'}], 'secondaryOutcomes': [{'measure': 'Average High-frequency Heart Rate Variability -- During Caregiving Episode', 'timeFrame': 'during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes', 'description': 'Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.'}, {'measure': 'Average High-frequency Heart Rate Variability -- Recovery', 'timeFrame': 'recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care', 'description': 'Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.'}, {'measure': 'Average Frequency of Skin Conductance Responses -- During Caregiving Episode', 'timeFrame': 'during caregiving episode, approximately 20 minutes', 'description': "Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving."}, {'measure': 'Average Frequency of Skin Conductance Responses -- Recovery', 'timeFrame': 'recovery, 30 minutes after intervention delivery or control period', 'description': "Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm infant', 'stress', 'nursing care', 'touch'], 'conditions': ['Prematurity', 'Stress Reaction']}, 'descriptionModule': {'briefSummary': 'Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.', 'detailedDescription': "Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born prematurely between 27 and 30 weeks post-menstrual age.\n* Born to mothers who are English-speaking and able to provide informed consent.\n* No more than 10 days old at the time of enrollment.\n\nExclusion Criteria:\n\n* Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.\n* Diagnosed with a congenital anomaly requiring surgery during the neonatal period.\n* Receiving scheduled steroids or vasopressors.\n* Skin conditions that preclude the attachment of sensors.\n* Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.\n* Diagnosed with chromosomal abnormalities.\n* Requiring special isolation with universal gloving for potentially infectious pathogens.'}, 'identificationModule': {'nctId': 'NCT05030233', 'acronym': 'P-NAT-BIO', 'briefTitle': 'Pilot Study of Nursing Touch and Biobehavioral Stress', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants', 'orgStudyIdInfo': {'id': '2021N0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse-Administered Touch Intervention', 'description': 'Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.', 'interventionNames': ['Behavioral: Nurse-Administered Touch Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Preterm infants will receive one episode of essential nursing care delivered as standard care.'}], 'interventions': [{'name': 'Nurse-Administered Touch Intervention', 'type': 'BEHAVIORAL', 'description': "The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.", 'armGroupLabels': ['Nurse-Administered Touch Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Marliese D. Nist, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': "Nationwide Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marliese Nist', 'investigatorAffiliation': 'Ohio State University'}}}}