Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-24 @ 5:02 PM
Study NCT ID:
NCT04082494
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2019-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001628', 'term': 'Beverages'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1613}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Wellbeing', 'timeFrame': '1 day after surgery', 'description': 'Assessed with the post anaesthesiological questionnaire (ANP) Wellbeing assessed with the "Anaesthesiological Questionnaire" (ANP) which is a self-rating method for the assessment of postoperative complaints and patient wellbeing. The rating scales from 0 to 3, with 0="none" and 3="strongly". Higher wellbeing values represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'approximately 2 hours after surgery', 'description': 'Numeric Rating Scale (NRS) in the postanaesthesia care unit. Pain will be assessed with the (verbal) Numerical Rating Scale (NRS) and statistically evaluated for differences between the two study groups. NRS scales from 1 to 10, with 1 describing the lowest pain score and 10 the highest pain score. Lower NRS describes a better outcome.'}, {'measure': 'Administered milligram of opioids for pain medication', 'timeFrame': 'approximately 2 hours after surgery', 'description': 'Assessment of administered morphine equivalents'}, {'measure': 'Postoperative complications in the postanaesthesia care unit', 'timeFrame': 'approximately 2 hours after surgery', 'description': 'Number of participants with following complications Delirium, postoperative cognitive dysfunction, postoperative nausea and vomiting, aspiration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wellbeing', 'Postoperative Pain', 'postoperative disturbances after anaesthesia'], 'conditions': ['Postoperative Complications', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': "Postoperative disturbances for patients' well-being in the PACU after general or spinal anaesthesia will be assessed. Influence of the offer of beverages and music will be assessed regarding their wellbeing, satisfaction and pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective stationary adult patients capable and willing of filling out the questionnaire\n\nExclusion Criteria:\n\n* participation in other studies about wellbeing influence\n* incapability of filling out the questionnaire\n* patients that do not wish to participate'}, 'identificationModule': {'nctId': 'NCT04082494', 'briefTitle': 'Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Impact on Postoperative Wellbeing in the PACU After General or Regional Anaesthesia Through Consecutive Implementation of Personalized Musical Entertainment and a Variety of Beverages. A Pre-post-post Analysis.', 'orgStudyIdInfo': {'id': 'Stand 04.03.2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular Treatment', 'description': 'No intervention is planned for the first period. "Baseline" treatment assesment.'}, {'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'Optional music via internet and noise canceling headphones will be offered.', 'interventionNames': ['Device: Music via internet and noise canceling headphones']}, {'type': 'EXPERIMENTAL', 'label': 'Music and Beverages', 'description': 'Additionally to the offered optional music via internet and noise canceling headphones, there will be beverages optionally offered (with and without sugar, warm or cold).', 'interventionNames': ['Device: Music via internet and noise canceling headphones', 'Other: Beverages']}], 'interventions': [{'name': 'Music via internet and noise canceling headphones', 'type': 'DEVICE', 'description': 'Optional music via internet and noise canceling headphones will be offered.', 'armGroupLabels': ['Music', 'Music and Beverages']}, {'name': 'Beverages', 'type': 'OTHER', 'description': 'Beverages will be optionally offered (with and without sugar, warm or cold).', 'armGroupLabels': ['Music and Beverages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Hospital LKH Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After publications of our data, we plan to share our data in respect of local privacy data laws.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}