Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT07050602
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Belief Model Nursing for Moderate to Severe OSAHS Post-Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': 'Baseline (immediately after operation) and 6 months post-intervention.', 'description': 'Measured by Polysomnography (PSG). Lower values indicate better outcome.'}, {'measure': 'OSAHS Recurrence Rate', 'timeFrame': '6 months and 12 months post-operation.', 'description': 'Calculated as the percentage of patients experiencing relapse (defined by AHI levels and symptom reappearance) within one year. Lower rates indicate better outcome.'}], 'secondaryOutcomes': [{'measure': 'Oxygen Desaturation Index (ODI)', 'timeFrame': 'Baseline (immediately after operation) and 6 months post-intervention.', 'description': 'Measured by Polysomnography (PSG). Lower values indicate better outcome.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) Score', 'timeFrame': 'Post-intervention (specific time point after 6 months or 1 year should be clarified, likely at 6 months and/or 1 year).', 'description': 'Assessed using the PSQI questionnaire (19 questions, 7 components, total score 0-21). Lower scores indicate better sleep quality.'}, {'measure': 'Self-Management Ability', 'timeFrame': 'Post-intervention (specific time point, likely at 6 months and/or 1 year).', 'description': 'Assessed by a questionnaire covering Knowledge Understanding, Adjustment of Daily Life, and Coping Strategies. Each dimension scored 0-10. Higher scores indicate better ability.'}, {'measure': 'Postoperative Quality of Life', 'timeFrame': 'Post-intervention (specific time point, likely at 6 months and/or 1 year).', 'description': 'Assessed by a self-designed questionnaire covering Sleep Quality, Daytime Function, Mental State, and Overall Satisfaction. Each category scored 0-10. Higher scores indicate better quality of life.'}, {'measure': 'Patient Satisfaction with Postoperative Care', 'timeFrame': '6 months post-intervention.', 'description': 'Assessed by a survey classifying satisfaction as Very Satisfied, Satisfied, General Satisfaction, Dissatisfied. Total satisfaction rate calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Belief Model', 'Moderate to Severe OSAHS', 'Postoperative Intervention', 'Nursing Intervention', 'Long-term Prevention'], 'conditions': ['Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)', 'Postoperative Care']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the long-term preventive and therapeutic effects of a health belief model (HBM)-based nursing intervention compared to routine care in patients with moderate to severe Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) after surgery. The study assessed impacts on sleep parameters (Apnea-Hypopnea Index, Oxygen Desaturation Index, sleep quality via PSQI), self-management abilities, quality of life, OSAHS recurrence rate, and patient satisfaction.', 'detailedDescription': 'A total of 120 post-surgery patients with moderate to severe OSAHS were recruited and assigned to either a control group (n=60) receiving routine postoperative care or an observation group (n=60) receiving a health belief model-based nursing intervention in addition to routine care. Routine care included general postoperative education for OSAHS, dietary, and exercise guidance with monthly phone follow-ups. The HBM intervention, lasting one year, focused on perceived susceptibility (assessment, psychological intervention), perceived severity (education on risks), perceived benefits (weight/BP monitoring, dietary/exercise guidance, sleep posture aids, daily diary), and perceived barriers (frequent phone follow-ups, psychological support). Outcomes were measured at baseline, 6 months, and 12 months post-surgery, including polysomnography, Pittsburgh Sleep Quality Index (PSQI), self-management ability questionnaires, quality of life questionnaires, OSAHS recurrence, and patient satisfaction surveys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 30 and 50 years old;\n* Sleep Apnea Hypopnea Index (AHI) \\> 21 events per hour;\n* Body Mass Index (BMI) ≥ 28 kg/m²;\n* The obstructive plane of OSAHS was either at the soft palate level or associated with narrowing at the tongue base level;\n* Surgical treatments included uvulopalatopharyngoplasty (UPPP) or UPPP combined with low-temperature plasma ablation of the tongue base/tongue body;\n* The patient had undergone surgical treatment for OSAHS;\n* The patient could comprehend the research details and voluntarily signed an informed consent form.\n\nExclusion Criteria:\n\n* Severe cardiovascular disease, kidney disease, liver disease, or dysfunction of other major organs;\n* Severe mental illness or cognitive dysfunction that would hinder understanding or adherence to research procedures;\n* Presence of other sleep disorders, such as central sleep apnea or insomnia;\n* Use of medications that could interfere with sleep patterns;\n* Pregnancy or lactation;\n* Patients unwilling to provide informed consent for the study.'}, 'identificationModule': {'nctId': 'NCT07050602', 'briefTitle': 'Health Belief Model Nursing for Moderate to Severe OSAHS Post-Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': 'Long-term Efficacy of Health Belief Model Nursing Intervention in Preventing and Treating Moderate to Severe OSAHS in Post-surgery Patients', 'orgStudyIdInfo': {'id': '20160703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observation Group', 'description': 'Participants received routine postoperative care plus a one-year health belief model nursing intervention. This included: comprehensive assessment and psychological interventions (Perceived Susceptibility); education on OSAHS risks and consequences (Perceived Severity); weekly weight/blood pressure monitoring, dietary/exercise guidance, sleep posture correction aids, and a daily health diary (Perceived Benefits); and regular phone follow-ups (2-3 times/week for 0-8 weeks post-discharge, bi-weekly up to 1 year) for support and addressing difficulties (Perceived Barriers).', 'interventionNames': ['Behavioral: Health Belief Model Nursing Intervention', 'Behavioral: Routine Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants received routine postoperative care for OSAHS for one year, including general education, dietary and exercise guidance. Post-discharge monitoring was conducted via monthly phone calls.', 'interventionNames': ['Behavioral: Routine Care']}], 'interventions': [{'name': 'Health Belief Model Nursing Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants received a one-year health belief model nursing intervention. This included: comprehensive assessment and psychological interventions (Perceived Susceptibility); education on OSAHS risks and consequences (Perceived Severity); weekly weight/blood pressure monitoring, dietary/exercise guidance, sleep posture correction aids, and a daily health diary (Perceived Benefits); and regular phone follow-ups (2-3 times/week for 0-8 weeks post-discharge, bi-weekly up to 1 year) for support and addressing difficulties (Perceived Barriers).', 'armGroupLabels': ['Observation Group']}, {'name': 'Routine Care', 'type': 'BEHAVIORAL', 'description': 'Participants received routine postoperative care for OSAHS for one year, including general education, dietary and exercise guidance. Post-discharge monitoring was conducted via monthly phone calls.', 'armGroupLabels': ['Control Group', 'Observation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Shuai Chen', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}