Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04528602
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2020-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Diaper Change Position on Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heart rate', 'timeFrame': 'Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.', 'description': 'Preterm infant will be monitored and heart rate will be monitored.'}, {'measure': 'Change in Respiratory Rate', 'timeFrame': 'Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.', 'description': 'Preterm infant will be monitored and respiratory rate will be monitored.'}, {'measure': 'Change in Oxygen Saturation', 'timeFrame': 'Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.', 'description': 'Preterm infant will be monitored and respiratory rate will be monitored.'}, {'measure': 'Change in Comfort', 'timeFrame': 'Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.', 'description': "Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The PICS evaluates seven parameters as Alertness, Calmness/Agitation, Respiratory Status (only on mechanic ventilation support) or Crying (not evaluated because it is scored in children with spontaneous breathing), Physical Movements, Muscle Tone, Facial Gestures and Mean Heart Rate. It is a five-point likert scale in which each element is scored from one to five (from bad to good). According to the PICS, the infant's comfort is evaluated over the total score. Accordingly, 35 points signify the lowest comfort score, while seven points signify the highest comfort score. High score obtained from the scale signifies that the comfort level is low. If the total score is ≥17, this is the cut-off value of the scale. It was found that the Turkish version was a valid and reliable."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm', 'diaper change', 'comfort', 'position'], 'conditions': ['Infant, Premature, Diseases']}, 'referencesModule': {'references': [{'pmid': '24548816', 'type': 'BACKGROUND', 'citation': 'Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.'}, {'pmid': '16507341', 'type': 'BACKGROUND', 'citation': 'Morelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. doi: 10.1016/j.earlhumdev.2005.12.013. Epub 2006 Feb 28.'}, {'pmid': '1519906', 'type': 'BACKGROUND', 'citation': 'Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. doi: 10.1097/00012272-199209000-00003.'}, {'pmid': '15231977', 'type': 'BACKGROUND', 'citation': 'Grunau RE, Weinberg J, Whitfield MF. Neonatal procedural pain and preterm infant cortisol response to novelty at 8 months. Pediatrics. 2004 Jul;114(1):e77-84. doi: 10.1542/peds.114.1.e77.'}, {'pmid': '27820087', 'type': 'BACKGROUND', 'citation': 'Picheansathian W, Woragidpoonpol P, Baosoung C. Positioning of Preterm Infants for Optimal Physiological Development: a systematic review. JBI Libr Syst Rev. 2009;7(7):224-259. doi: 10.11124/01938924-200907070-00001.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.', 'detailedDescription': "This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.\n\nDuring the data collection process, two methods will be applied to preterm infants during diaper change.\n\nIn the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.\n\nThe researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The preterm infants whose\n* Parents have agreed to participate in the study and have signed the informed consent form,\n* Who have no congenital anomalies,\n* Have no chronic illnesses,\n* Have undergone Underwent no surgical procedures,\n* Have no neurological symptoms,\n* Have not been diagnosed with sepsis,\n* Have not been sedated,\n* Have not received any pharmacological analgesic method four hours before,\n* Have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included.\n\nExclusion Criteria:\n\nThe preterm infants whose\n\n* Parents have not agreed to participate in the study and have not signed the informed consent form,\n* Who have congenital anomalies,\n* Have chronic illnesses,\n* Have undergone surgical procedures,\n* Have neurological symptoms,\n* Have been diagnosed with sepsis,\n* Have been sedated,\n* Have received pharmacological analgesic methods four hours before,\n* Were between \\<28 and \\>36+6 gestational weeks, will be excluded.'}, 'identificationModule': {'nctId': 'NCT04528602', 'briefTitle': 'The Effect of Diaper Change Position on Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants', 'orgStudyIdInfo': {'id': '2019-5/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control (Extended leg position) Group', 'description': 'In the control (Extended leg position) group of the study, diaper change will be performed after the legs of the babies are brought to extension.', 'interventionNames': ['Procedure: Control (Extended leg position) Group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental (Legs are flexed toward abdomen) Group', 'description': 'In the experimental (Legs are flexed toward abdomen) group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen while maintaining their flexion leg position.', 'interventionNames': ['Procedure: Experimental (Legs are flexed toward abdomen) Group']}], 'interventions': [{'name': 'Control (Extended leg position) Group', 'type': 'PROCEDURE', 'description': "Common procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared.\n\nHands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened.\n\nFor the Control Group\n\n-The infant will be grasped on the legs, the legs will be given extension position and lifted up.\n\nThe dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.\n\nThe infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed.\n\nThe infant's legs will be given in extension position and a clean diaper will be placed under them.\n\nTapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application.", 'armGroupLabels': ['Control (Extended leg position) Group']}, {'name': 'Experimental (Legs are flexed toward abdomen) Group', 'type': 'PROCEDURE', 'description': "Procedure steps for the Experimental Group\n\n* Common procedure steps\n* The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen.\n* The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.\n* The infant's feet will be freed.\n* The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin.\n* The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary.\n* Tapes of the clean diaper will be fastened.\n* Hands will be washed after the procedure.\n* Data will be collected immediately before, during, immediately after and 3 minutes after the end of application.", 'armGroupLabels': ['Experimental (Legs are flexed toward abdomen) Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Atasehir', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Zehra Kan Öntürk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zehra Kan Onturk', 'investigatorAffiliation': 'Acibadem University'}}}}