Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04206956
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2019-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006554', 'term': 'Hernia, Umbilical'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's preoperative anxiety", 'timeFrame': 'Preoperative : day of surgery', 'description': '\\- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale).\n\nIf the score is less than 24 : quiet child. If the score is greater than 24 : anxious child\n\n\\- For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)'}, {'measure': "Parents' preoperative anxiety", 'timeFrame': 'Preoperative: day of surgery', 'description': 'anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"'}, {'measure': "children's pain", 'timeFrame': 'postoperative: day of surgery', 'description': '* for children younger than 6: Evendol scale. From 0 (better) to 15 (worse)\n* for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).'}, {'measure': 'Chronic postsurgical pain in children', 'timeFrame': '3 months after surgery', 'description': 'For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric department', 'children', 'chronic postsurgical pain', 'perioperative anxiety'], 'conditions': ['Ambulatory Surgery', 'Children, Only', 'Inguinal Hernia', 'Umbilical Hernia', 'Urologic Surgery']}, 'referencesModule': {'references': [{'pmid': '28363861', 'type': 'BACKGROUND', 'citation': 'Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.'}, {'pmid': '28077537', 'type': 'BACKGROUND', 'citation': 'Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.'}, {'pmid': '31335643', 'type': 'BACKGROUND', 'citation': "Noel M, Rosenbloom B, Pavlova M, Campbell F, Isaac L, Page MG, Stinson J, Katz J. Remembering the pain of surgery 1 year later: a longitudinal examination of anxiety in children's pain memory development. Pain. 2019 Aug;160(8):1729-1739. doi: 10.1097/j.pain.0000000000001582."}, {'pmid': '23865442', 'type': 'BACKGROUND', 'citation': 'Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.'}, {'pmid': '24109194', 'type': 'BACKGROUND', 'citation': 'Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.'}, {'pmid': '26381701', 'type': 'BACKGROUND', 'citation': 'Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.'}, {'pmid': '28598902', 'type': 'BACKGROUND', 'citation': 'Birnie KA, Chorney J, El-Hawary R; PORSCHE Study Group. Child and parent pain catastrophizing and pain from presurgery to 6 weeks postsurgery: examination of cross-sectional and longitudinal actor-partner effects. Pain. 2017 Oct;158(10):1886-1892. doi: 10.1097/j.pain.0000000000000976.'}, {'pmid': '22831892', 'type': 'BACKGROUND', 'citation': 'Kristensen AD, Ahlburg P, Lauridsen MC, Jensen TS, Nikolajsen L. Chronic pain after inguinal hernia repair in children. Br J Anaesth. 2012 Oct;109(4):603-8. doi: 10.1093/bja/aes250. Epub 2012 Jul 24.'}, {'pmid': '29352738', 'type': 'BACKGROUND', 'citation': 'Mossetti V, Boretsky K, Astuto M, Locatelli BG, Zurakowski D, Lio R, Nicoletti R, Sonzogni V, Maffioletti M, Vicchio N, Ivani G. Persistent pain following common outpatient surgeries in children: A multicenter study in Italy. Paediatr Anaesth. 2018 Mar;28(3):231-236. doi: 10.1111/pan.13321. Epub 2018 Jan 20.'}, {'pmid': '23063345', 'type': 'BACKGROUND', 'citation': 'Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.', 'detailedDescription': "The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.\n\nFor children, there is few data about predictive factors of postoperative pain after ambulatory surgery.\n\nThe objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children undergoing scheduled abdominal or urologic ambulatory surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child from 3 to 18 years old\n* undergoing scheduled urology or abdominal ambulatory surgery\n* child and parents speaking French\n* affiliation to national health insurance\n\nExclusion Criteria:\n\n* emergency surgery\n* lack of parents consent\n* no parental support on surgery day'}, 'identificationModule': {'nctId': 'NCT04206956', 'acronym': 'ANXIDOU', 'briefTitle': 'Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Brieuc'}, 'officialTitle': 'Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children', 'orgStudyIdInfo': {'id': 'CHSB-2019-05-P2-ANXIDOU'}}, 'contactsLocationsModule': {'locations': [{'zip': '22027', 'city': 'Saint-Brieuc', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenaëlle Le Garff', 'role': 'CONTACT', 'email': 'gwenaelle.legarff@armorsante.bzh', 'phone': '+33296017277'}, {'name': 'Catherine Bellot', 'role': 'CONTACT', 'email': 'catherine.bellot@armorsante.bzh', 'phone': '+33296017340'}, {'name': 'Claire Barbarot, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Saint-Brieuc', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}], 'centralContacts': [{'name': 'Gwenaelle Le Garff, Dr', 'role': 'CONTACT', 'email': 'gwenaelle.legarff@armorsante.bzh', 'phone': '+33296017277'}, {'name': 'Catherine Bellot', 'role': 'CONTACT', 'email': 'catherine.bellot@armorsante.bzh', 'phone': '+33296017340'}], 'overallOfficials': [{'name': 'Claire Barbarot, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hopsitalier Saint-Brieuc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Brieuc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}