Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-03 @ 11:45 PM
Study NCT ID:
NCT04041635
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D000073818', 'term': 'Pain, Procedural'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Premature Infant Pain Profile (PIPP) score', 'timeFrame': 'From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture', 'description': 'Calculation of pain response using a validated instrument (Premature Infant Pain Profile-PIPP). It varies from "0" (no pain to 21 (maximum pain response)'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture', 'description': 'Heart rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Premature', 'Visual stimuli', 'Auditory stimuli'], 'conditions': ['Premature', 'Pain, Procedural']}, 'referencesModule': {'references': [{'pmid': '31865625', 'type': 'DERIVED', 'citation': 'Bonjorn Juarez M, Manrique Pons M, Grau Alcon L, Martinez-Momblan MA, Alonso-Fernandez S. Reduction of visual and auditory stimuli to reduce pain during venipuncture in premature infants. Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Apr;76(4):1077-1081. doi: 10.1111/jan.14300. Epub 2020 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.', 'detailedDescription': 'Background: The evidence for the efficacy of reducing sensory stimulation and its effect on pain in minor procedures has not been studied in depth. There are no studies that evaluate the reduction of visual and auditory stimuli in a combined way.\n\nImpact: It is easy to incorporate the reduction of visual and auditory stimuli into nursing practice.\n\nAims: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.\n\nDesign: Open, randomized, non-blind parallel clinical trial. Methods: Study to take place at the neonatal intensive care unit at the Germans Trias i Pujol University Hospital in 2019-2021. 56 recently born babies between 32 and 36 weeks of gestation will participate. The dependent variable is level of pain determined using the Premature Infant Pain Profile (PIPP). The intervention will be assigned randomly using the random.org software. Data analysis will be carried out using the IBM SPSS v.25 software assuming a level of significance of 5%.\n\nThe results of this study could have a direct impact on clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature babies born between 32 and 36 weeks of gestation (both included).\n* Haemodynamically stable.\n* Require venipuncture and whose.\n* Parents or legal guardians have signed informed consent forms.\n\nExclusion Criteria:\n\n* Gestational age inferior to 32 weeks.\n* Treated with intravenous or oral analgesics, sedatives or relaxants.\n* Critical status or haemodynamically unstable.\n* Requiring invasive mechanical ventilation.'}, 'identificationModule': {'nctId': 'NCT04041635', 'acronym': 'VENOPUNCIPREM', 'briefTitle': 'Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'PI-18-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stimuli Reduction', 'description': 'This group will receive reduced visual and auditory stimuli in addition to usual care during venipuncture. Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure.', 'interventionNames': ['Procedure: Stimuli reduction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced.', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'Stimuli reduction', 'type': 'PROCEDURE', 'description': 'Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure.', 'armGroupLabels': ['Stimuli Reduction']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sergio Alonso-Fernández, RN', 'role': 'CONTACT', 'email': 'salonso.germanstrias@gencat.cat', 'phone': '0034934978437'}, {'name': 'Maria Bonjorn-Juarez, RN', 'role': 'CONTACT', 'email': 'mariabonjornjuarez@gmail.com', 'phone': '0034934978926'}, {'name': 'Maria Bonjorn-Juarez, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laia Grau-Alcon, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meritxell Manrique-Pons, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Antonia Martinez-Momblan, RN,MSN,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sergio Alonso-Fernández, RN,MSN,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'centralContacts': [{'name': 'Sergio Alonso-Fernández, RN', 'role': 'CONTACT', 'email': 'salonso.germanstrias@gencat.cat', 'phone': '0034934978437'}, {'name': 'Maria Bonjorn-Juarez, RN', 'role': 'CONTACT', 'email': 'mariabonjornjuarez@gmail.com', 'phone': '0034678116280'}], 'overallOfficials': [{'name': 'Maria Bonjorn-Juarez, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació Institut Germans Trias i Pujol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}