Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT03915093
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prehabilitation Protocol on Quality of Life After Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of prehabilitation on quality of life after thoracoscopic surgery', 'timeFrame': 'after one month postoperative', 'description': 'WHOQOL developed by WHO (2004). It contains 5 broad domains of QOL within which 18 facets are covered to determine the quality of life. These 5 domains include physical, social, psychological, environmental and perceived QOL. Within each domain several sub domains (facets) of QOL Summarize that particular domain of QOL.The scoring of these variables, a 3-point lickert scale on tables was adopted for the answer low QOL=0-3, moderate QOL=4-6, and high QOL =7-9.'}], 'secondaryOutcomes': [{'measure': 'effect of prehabilitation on duration of hospital stay after thoracoscopic surgery', 'timeFrame': 'immediate post operative', 'description': 'assess length of hospital stay postoperative for both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracoscopy', 'Educational nursing protocol', 'Quality of life'], 'conditions': ['Thoracoscopy', 'Prehabilitation']}, 'referencesModule': {'references': [{'pmid': '26941973', 'type': 'BACKGROUND', 'citation': 'Yeung WW. Post-operative care to promote recovery for thoracic surgical patients: a nursing perspective. J Thorac Dis. 2016 Feb;8(Suppl 1):S71-7. doi: 10.3978/j.issn.2072-1439.2015.10.68.'}, {'pmid': '26273399', 'type': 'BACKGROUND', 'citation': 'Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.'}]}, 'descriptionModule': {'briefSummary': "video-assisted thoracic surgery (VATS) is a new approach used in cardio thoracic surgery department instead of thoracotomy to treat several diseases.patients underwent thoracoscopic surgery without organized educational protocol either before or after the procedure. Therefore, this study will be the first clinical research which will increase patients' knowledge about thoracoscopy and decrease its complications.", 'detailedDescription': 'The role of thoracic nursing specialty is to support and educate patients, who are suffering from thoracic diseases, to achieve the best outcome in terms of physical, psychological, social and spiritual well beings. The care provided not only focuses on in-hospital treatments that patient received, but also encompasses the whole patient journey including lifestyle modification, health concept promotion, self-empowerment and secondary prevention. Preoperative prophylactic physiotherapy has been shown to be an important and effective approach in preventing or reducing postoperative complications, in addition to optimizing treatment by familiarizing the patient with the physiotherapeutic procedures. Quasi experimental research design was utilized to conduct this study.Sixty adult patients undergoing thoracoscopic surgery included and had the following criteria, the age ranged from 18-65 years old, both male and female. The patients divided into two equal groups (study and control groups), 30 patients for each. The study group received educational nursing protocol while the control group received the routine hospital care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergoing thoracoscopic surgery\n* Age 18-65 year\n* patients who agree to participate in the study\n\nExclusion Criteria:\n\n* converting to thoracotomy\n* patients refuse to participate'}, 'identificationModule': {'nctId': 'NCT03915093', 'acronym': 'VATS', 'briefTitle': 'Effect of Prehabilitation Protocol on Quality of Life After Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Thoracoscopic Surgery: Effect of Designing and Implementing Educational Nursing Protocol on Patients Quality of Life', 'orgStudyIdInfo': {'id': '1562017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'receive educational nursing protocol', 'interventionNames': ['Other: Educational nursing protocol', 'Other: Routine hospital care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'receive routine hospital care', 'interventionNames': ['Other: Routine hospital care']}], 'interventions': [{'name': 'Educational nursing protocol', 'type': 'OTHER', 'description': 'It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions', 'armGroupLabels': ['study group']}, {'name': 'Routine hospital care', 'type': 'OTHER', 'description': 'The routine care given by physicians and nurses after thoracoscopic surgery', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut U', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hussein El Khayat', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of medicine'}, {'name': 'Sahra Azer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of nursing'}, {'name': 'Magda Mohamed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant lecturer', 'investigatorFullName': 'Maha Nafady Abd El Hafez', 'investigatorAffiliation': 'Assiut University'}}}}