Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06793618
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2025-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized control trial with one intervention and one control group. post-test only'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal/ Infant Pain Scale', 'timeFrame': 'from the process of enrollment at the post-natal ward until the IM injection is administered (usually takes less than 1 hour)', 'description': 'A scale developed specifically for newborn infants. Consists of 6 criterion (Face Expression, cry, Patterns of Breathing, leg and arm movements, Arousal status) Recommended for children less than 1 year old.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'non-pharmacological pain managment'], 'conditions': ['Intramuscular Injection', 'Neonates', 'Neonatal Pain']}, 'descriptionModule': {'briefSummary': 'A quantitative study, true experimental, posttest-only design has been used for the current study. one intervention (the Z-track technique) and one control group involved in the study. The primary outcome measure is the Neonatal/Infant Pain Scale to be used immediately after intramuscular injections to measure the pain level among neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'minimumAge': '5 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates delivered through cesarean section\n* Apgar score of 8 or more\n* Weight between 2500 - 3500 grams\n* neonates receiving IM injections\n* Males / females\n* term neonates between 37th and 42nd week of gestation\n\nExclusion Criteria:\n\n* Congenital anomalies\n* neonates who received intramuscular injection such as the Hepatitis B vaccine\n* Low birth weight\n* Preterms\n* Neural tube defects\n* neonates who are of normal vaginal delivery'}, 'identificationModule': {'nctId': 'NCT06793618', 'briefTitle': 'Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NO. 37/ 2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Z-track technique', 'description': "To perform the zeta-track technique: In this method, the neonates are in supine position, the skin is moved and held from the injection site 2 to 3 cm to the side or downward using the non- dominant hand, to ensure that blood vessel wasn't penetrated aspiration on the syringe must perceive the injection and then the medication is to be injected slowly. Researcher assistant that is unaware of the injection method performs the recording of the pain intensity and leakage diameter on the observation form.", 'interventionNames': ['Other: Z-track technique']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'the neonates receive the intramuscular injection using the conventional method and protocol used in the postnatal ward without any interventions'}], 'interventions': [{'name': 'Z-track technique', 'type': 'OTHER', 'description': "In this method, the neonates are in supine position, the skin is moved and held from the injection site 2 to 3 cm to the side or downward using the non- dominant hand, to ensure that blood vessel wasn't penetrated aspiration on the syringe must perceive the injection and then the medication is to be injected slowly. Researcher assistant that is unaware of the injection method performs the recording of the pain intensity and leakage diameter on the observation form.", 'armGroupLabels': ['Z-track technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66001', 'city': 'Samawah', 'state': 'Muthanna Governorate', 'country': 'Iraq', 'facility': 'Feminine and Children Educational Hospital', 'geoPoint': {'lat': 31.33198, 'lon': 45.2944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Nurse', 'investigatorFullName': 'Haider Jumaa Kareem', 'investigatorAffiliation': 'University of Baghdad'}}}}