Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 5:33 AM
Study NCT ID:
NCT01503060
Status:
UNKNOWN
Last Update Posted:
2015-11-10
First Post:
2011-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
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': 'D014867', 'term': 'Water'}, {'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypersensitivity to pain', 'timeFrame': 'At 15 month vaccination (Visit 5)', 'description': 'This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of interventions', 'timeFrame': 'At 2,4,6,12 month vaccinations (Visit 1-4)', 'description': 'This will be assessed by comparing the pain scores between groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatrics', 'Pain', 'Immunization'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '28455250', 'type': 'DERIVED', 'citation': 'Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.'}, {'pmid': '27956393', 'type': 'DERIVED', 'citation': 'Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Healthy infants undergoing vaccination.\n\nExclusion Criteria:\n\n1. preterm birth (\\<37 weeks gestation)\n2. prior hospitalization/surgery (other than postnatal care),\n3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,\n4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.'}, 'identificationModule': {'nctId': 'NCT01503060', 'briefTitle': 'Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1000025726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': '* Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care\n* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.', 'interventionNames': ['Behavioral: Educational Video - Sham', 'Drug: Sucrose Placebo (water)', 'Drug: Lidocaine Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain\n* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.', 'interventionNames': ['Behavioral: Educational video - Active', 'Drug: Sucrose Placebo (water)', 'Drug: Lidocaine Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar\n* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.', 'interventionNames': ['Behavioral: Educational video - Active', 'Drug: Sucrose', 'Drug: Lidocaine Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': '* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic\n* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.', 'interventionNames': ['Behavioral: Educational video - Active', 'Drug: Sucrose', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Educational video - Active', 'type': 'BEHAVIORAL', 'description': 'The active video will instruct parents in techniques related to optimal infant soothing.', 'armGroupLabels': ['Group 2', 'Group 3', 'Group 4']}, {'name': 'Educational Video - Sham', 'type': 'BEHAVIORAL', 'description': 'The sham video will provide general information about immunization immunization pain management.', 'armGroupLabels': ['Group 1']}, {'name': 'Sucrose Placebo (water)', 'type': 'DRUG', 'description': 'Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Sucrose', 'type': 'DRUG', 'description': 'Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination', 'armGroupLabels': ['Group 3', 'Group 4']}, {'name': 'Lidocaine Placebo', 'type': 'DRUG', 'description': 'Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4V 2S2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Moshe Ipp, MD', 'role': 'CONTACT', 'email': 'moshe.ipp@sickkids.ca', 'phone': '(416) 924-7171'}, {'name': 'Moshe Ipp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Outpatient Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5V1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT'}, {'name': 'Anna Taddio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moshe Ipp, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@sickkids.ca', 'phone': '416-813-6235'}], 'overallOfficials': [{'name': 'Anna Taddio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Scientist/Pharmacist', 'investigatorFullName': 'Anna Taddio', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}