Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:48 PM
Study NCT ID:
NCT07337668
Status:
COMPLETED
Last Update Posted:
2026-03-09
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D012917', 'term': 'Social Adjustment'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-04', 'studyFirstSubmitQcDate': '2026-01-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Baseline and postoperative 21 days', 'description': 'Depression level was assessed using the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-report questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms'}, {'measure': 'Social Adaptation', 'timeFrame': 'Baseline and postoperative 21 days', 'description': 'Social adaptation was assessed using the Social Adaptation Self-evaluation Scale. The Social Adaptation Self-Evaluation Scale is a self-report instrument designed to evaluate social functioning and adaptation. Total scores range from 0 to 60, with higher scores indicating better social adaptation and functioning'}, {'measure': 'Quality of Recovery', 'timeFrame': 'Postoperative 21 days', 'description': 'Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. The Quality of Recovery-40 is a validated questionnaire assessing postoperative recovery across five dimensions: emotional state, physical comfort, psychological support, physical independence, and pain. Total scores range from 40 to 200, with higher scores indicating better quality of recovery'}], 'secondaryOutcomes': [{'measure': 'Swallowing Function', 'timeFrame': 'Baseline and postoperative 21 days', 'description': 'Swallowing function was assessed using the Turkish version of the Eating Assessment Tool-10 (T-EAT-10).The Turkish Version of the Eating Assessment Tool-10 is a self-administered questionnaire used to assess symptoms of dysphagia. Total scores range from 0 to 40, with higher scores indicating more severe swallowing difficulties'}, {'measure': 'Oral Care Status', 'timeFrame': 'Postoperative 21 days', 'description': 'Oral care status was assessed using an oral care assessment tool. Total scores range from 8 to 24, with higher scores indicating poorer oral condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile application', 'tracheostomy', 'education', 'quality of recovery', 'depression', 'social adaptation'], 'conditions': ['Tracheostomized Patients', 'Depression', 'Social Adaptation', 'Quality of Recovery']}, 'referencesModule': {'references': [{'pmid': '18791882', 'type': 'BACKGROUND', 'citation': 'Akkaya C, Sarandol A, Esen Danaci A, Sivrioglu EY, Kaya E, Kirli S. [Reliability and validity of the Turkish version of the Social Adaptation Self-Evaluation Scale (SASS)]. Turk Psikiyatri Derg. 2008 Fall;19(3):292-9. Turkish.'}, {'pmid': '27405421', 'type': 'BACKGROUND', 'citation': 'Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.'}, {'pmid': '24428925', 'type': 'BACKGROUND', 'citation': 'Karaman S, Arici S, Dogru S, Karaman T, Tapar H, Kaya Z, Suren M, Gurler Balta M. Validation of the Turkish version of the Quality of Recovery-40 questionnaire. Health Qual Life Outcomes. 2014 Jan 15;12:8. doi: 10.1186/1477-7525-12-8.'}, {'pmid': '13688369', 'type': 'BACKGROUND', 'citation': 'BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery', 'detailedDescription': 'The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older\n* Patients with a tracheostomy\n* Able to communicate verbally or in writing\n* Able to use a smartphone\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Presence of severe cognitive impairment\n* Presence of severe psychiatric disorder\n* Patients with neurological diseases affecting swallowing\n* Inability to use a mobile application\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07337668', 'briefTitle': 'The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery', 'orgStudyIdInfo': {'id': 'Tracheostomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in this group received standard care plus a mobile application-based education program designed for patients with tracheostomy. The program included educational videos focusing on tracheostomy care, psychosocial support, and postoperative recovery.', 'interventionNames': ['Behavioral: Mobile application-based education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in this group received standard postoperative care without access to the mobile application-based education program.', 'interventionNames': ['Other: Standart Care']}], 'interventions': [{'name': 'Mobile application-based education', 'type': 'BEHAVIORAL', 'description': 'A structured education program delivered via a mobile application for patients with tracheostomy. The program included educational videos focusing on tracheostomy care, and postoperative recovery. Participants accessed the content throughout the postoperative period in addition to standard care.', 'armGroupLabels': ['Intervention group']}, {'name': 'Standart Care', 'type': 'OTHER', 'description': 'Standard postoperative care routinely provided to patients with tracheostomy according to institutional protocols', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Basaksehir Cam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}