Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT03488459
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2018-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety intensity scores', 'timeFrame': 'day prior to surgery, postoperative day 2', 'description': 'Anxiety was determined with a Polish version of the self-inventory, either for children between 9 and 14 years of age, i.e. State-Trait Anxiety Inventory for Children (STAI-C; range: 20-60 pts) or for adolescents, i.e. State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. In this study, the levels of anxiety were determined twice: one day prior to surgery (both trait and state anxiety) and 48 h after the procedure (only state anxiety). The results were expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, \\>7 = high level of anxiety).'}], 'secondaryOutcomes': [{'measure': 'Pain intensity scores at rest', 'timeFrame': 'postoperative hours: 1, 2, 4, 11, 24, 48', 'description': 'The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.'}, {'measure': 'Pain intensity scores during deep breathing', 'timeFrame': 'postoperative hours: 1, 2, 4, 11, 24, 48', 'description': 'The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.'}, {'measure': 'Pain intensity scores during coughing', 'timeFrame': 'postoperative hours: 1, 2, 4, 11, 24, 48', 'description': 'The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'postoperative day 2', 'description': 'Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'preoperative education', 'psychologist', 'thoracotomy', 'Ravitch procedure', 'postoperative pain'], 'conditions': ['Pain, Postoperative', 'Surgery, Thoracic']}, 'referencesModule': {'references': [{'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': '23289773', 'type': 'BACKGROUND', 'citation': 'Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.'}, {'pmid': '22300416', 'type': 'BACKGROUND', 'citation': 'Fincher W, Shaw J, Ramelet AS. The effectiveness of a standardised preoperative preparation in reducing child and parent anxiety: a single-blind randomised controlled trial. J Clin Nurs. 2012 Apr;21(7-8):946-55. doi: 10.1111/j.1365-2702.2011.03973.x. Epub 2012 Feb 3.'}, {'pmid': '30305761', 'type': 'DERIVED', 'citation': 'Tomaszek L, Cepuch G, Fenikowski D. Influence of preoperative information support on anxiety, pain and satisfaction with postoperative analgesia in children and adolescents after thoracic surgery: A randomized double blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):172-178. doi: 10.5507/bp.2018.060. Epub 2018 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.', 'detailedDescription': 'The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* thoracic surgery (lateral thoracotomy or Ravitch procedure),\n* the American Society of Anesthesiologists score 1 or 2.\n\nExclusion Criteria:\n\n* presence of a mental disorder,\n* anticancer treatment,\n* preoperative pain,\n* problems with verbal communication ,\n* lack of postoperative drainage of the chest.'}, 'identificationModule': {'nctId': 'NCT03488459', 'briefTitle': 'Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'National Institute for Tuberculosis and Lung Diseases, Poland'}, 'officialTitle': 'Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study', 'orgStudyIdInfo': {'id': '10.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Routine preoperative information from a nurse', 'interventionNames': ['Behavioral: Routine preoperative information from a nurse']}, {'type': 'EXPERIMENTAL', 'label': 'Additional information support from a psychologist', 'interventionNames': ['Behavioral: Additional information support from a psychologist']}], 'interventions': [{'name': 'Routine preoperative information from a nurse', 'type': 'BEHAVIORAL', 'description': 'Routine preoperative information from a nurse.', 'armGroupLabels': ['Routine preoperative information from a nurse']}, {'name': 'Additional information support from a psychologist', 'type': 'BEHAVIORAL', 'description': 'Routine preoperative information from a nurse + additional information support from a psychologist.', 'armGroupLabels': ['Additional information support from a psychologist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34-700', 'city': 'Rabka-Zdrój', 'state': 'Małopolska', 'country': 'Poland', 'facility': 'Institute for Tuberculosis and Lung Diseases, Pediatric Division', 'geoPoint': {'lat': 49.60889, 'lon': 19.96654}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute for Tuberculosis and Lung Diseases, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}