Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06610656
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2024-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041361', 'term': 'Pacifiers'}], 'ancestors': [{'id': 'D015370', 'term': 'Infant Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'n this study, both participants and investigators are masked to the group assignment. Participants will not be aware of whether they are receiving pacifier therapy alone or in combination with white noise therapy. Investigators will not know the specific group assignments during the intervention to minimize bias in observations and assessments.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a parallel assignment design in which participants are assigned to one of two intervention groups. Group 1 will receive pacifier and white noise therapy, while Group 2 will receive pacifier therapy only. Each group will be treated independently, and there will be no crossover between the groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Neonatal Pain Scale (NIPS', 'timeFrame': '20 minutes', 'description': 'The factors evaluated in the newborn baby pain scale are facial expression, arms, legs, oxygen saturation, arousal, breathing pattern, crying, heart rate. It can be preferred in post-operative pain. It can be used in procedural pain. It has a total of 8 parameters. The highest score can be given is 7. 0 points = no pain, 1-2 points = mild pain, 3-4 points = moderate pain, \\>4 points = severe pain is accepted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['white noise', 'pacifier', 'newborn', 'surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery', 'detailedDescription': 'Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight over 1500 grams\n\n * Having passed the newborn hearing screening test\n * Having a history of previous surgery (excluding brain surgeries)\n * Not using sedative substances (dormicum, fentanyl)\n * Not using opioids\n * Having a full stomach 30 minutes before painful interventions\n * Having permission from their mothers\n * Newborns undergoing blood transfusion only\n\nExclusion Criteria:\n\n* Being intubated\n\n * Having hiberbilirubinemia\n * Birth weight below 1500 grams\n * Having cerebral palsy\n * Having hydrocephalus\n * Having spina bifida\n * Having had brain surgery'}, 'identificationModule': {'nctId': 'NCT06610656', 'acronym': 'CLİNİCAL', 'briefTitle': 'White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Yuksek Ihtisas University'}, 'officialTitle': 'The Effect of White Noise and Pacifier Applications on Pain and Crying Time in Newborns in the Postoperative Period', 'orgStudyIdInfo': {'id': 'ABAHAR-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'White noise and pacifier applications group', 'description': 'In this group, infants will receive pacifier and white noise therapy. The white noise will be used to enhance the quality of sleep and reduce restlessness in infants. During the intervention, participants will receive pacifiers, and white noise will be continuously administered.', 'interventionNames': ['Other: Pacifier and White Noise Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pacifier applications group', 'description': 'In this group, infants will receive only pacifier therapy. The aim is to provide comfort and support for sleep through the use of pacifiers. White noise will not be utilized in this group. This intervention focuses solely on assessing the effects of pacifier use without any additional auditory stimuli', 'interventionNames': ['Other: pacifier therapy']}], 'interventions': [{'name': 'Pacifier and White Noise Therapy', 'type': 'OTHER', 'description': 'Infants will receive both pacifier and white noise therapy to enhance sleep quality and reduce restlessness', 'armGroupLabels': ['White noise and pacifier applications group']}, {'name': 'pacifier therapy', 'type': 'OTHER', 'description': 'Infants will receive pacifier therapy to enhance sleep quality and reduce restlessness', 'armGroupLabels': ['pacifier applications group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62510', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Yüksek Ihtisas Üniversity', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'arzu bahar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yüksek Ihtisas University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuksek Ihtisas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Pofessor', 'investigatorFullName': 'Arzu Bahar', 'investigatorAffiliation': 'Yuksek Ihtisas University'}}}}