Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT06131034
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area of residence', 'timeFrame': 'At baseline', 'description': 'Using postal code of current address'}, {'measure': 'General medication use (incidence and concentration)', 'timeFrame': 'Before and during admittance, retrospectively, with a maximum of day 30 postoperatively', 'description': 'Medication use that could be of influence on sleep quality'}, {'measure': 'Physical parameter, bloodpressure', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'in mm/Hg'}, {'measure': 'Physical parameter, pulse rate', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'beats/min'}, {'measure': 'Physical parameter, respiratory rate', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'Resp/min'}, {'measure': 'Perioperative complications', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'Number of patients with medical complications, and grading of these complications using Clavien Dindo and the Comprehensive Complication Index (CCI)'}, {'measure': 'Clinical information checklist', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'Information about type of surgery, selected medical history, age, gender, hospital length of stay'}], 'primaryOutcomes': [{'measure': 'Subjective sleep quality assessed using a questionnaire', 'timeFrame': 'On the morning of day 2, 3 and 4 at the surgical ward', 'description': 'Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance questionnaire, raw summary score'}], 'secondaryOutcomes': [{'measure': 'Subjective sleep quantity', 'timeFrame': 'During the (possible) intervention period, until day 5 postoperatively', 'description': 'Using the adapted Consensus Sleeping Diary'}, {'measure': 'Objective sleep assessment', 'timeFrame': 'During the (possible) intervention period, until day 5 postoperatively', 'description': 'Measured with an actigraphy device'}, {'measure': 'Music listening during study period', 'timeFrame': 'During the (possible) intervention period, until day 5 postoperatively', 'description': 'Using a diary'}, {'measure': 'Anxiety', 'timeFrame': 'Every morning during the (possible) intervention period, until day 5 postoperatively', 'description': 'Using the The State-Trait Anxiety Inventory-6 (STAI-6), 20-80, with a high score being a worse outcome'}, {'measure': 'Subclinical stess using', 'timeFrame': 'At baseline and at the end of the (possible) intervention period, at day 5 postoperatively', 'description': 'Using the Subclinical Stress Symptoms Questionnaire (SSQ-25).'}, {'measure': 'Postoperative quality of recovery using a questionnaire', 'timeFrame': 'At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge', 'description': 'Quality of Recovery-40 score (QOR-40)'}, {'measure': 'Patient satisfaction using a self-made questionnaire', 'timeFrame': 'At the end of the study period, 30 days after discharge', 'description': 'A Likert scale will be used, 0 -10, with a higher score meaning a more satisfied feeling regarding the hospital admittance.'}, {'measure': 'Music preference and importance in daily life', 'timeFrame': 'At baseline', 'description': 'Using a questionnaire with use of multiple chose questions and a Likert scale, 0 - 10, with a higher score resulting in a more positive attitude towards music'}, {'measure': 'Cost consequences and cost-effectiveness', 'timeFrame': '30 days after discharge', 'description': 'Using the Institute for Medical Technology Assessment (iMTA) medical consumption questionnaire and the iMTA productivity loss questionnaire'}, {'measure': 'Cost consequences and cost-effectiveness', 'timeFrame': '30 days after discharge', 'description': 'Using the Institute for Medical Technology Assessment (iMTA) productivity loss questionnaire'}, {'measure': 'Quality of life score', 'timeFrame': 'At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge', 'description': 'Using the EuroQol-5dimension-5length (EQ-5D-5L), with a score of 0 - 100, where a higher score'}, {'measure': 'Delirium incidence', 'timeFrame': 'During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.', 'description': 'Delirium Observation Scale per day and delirium diagnosis (defined as diagnosis by clinician)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '41326266', 'type': 'DERIVED', 'citation': 'Stoop JM, Geensen R, Louter M, Poley MJ, Verhoef C, Jeekel J, Klimek M. The DREAMERS-trial: A randomized controlled trial protocol addressing the use of perioperative music to prevent sleep disturbances in hospitalized surgical patients. Contemp Clin Trials. 2025 Dec;159:108129. doi: 10.1016/j.cct.2025.108129. Epub 2025 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Patients undergoing major elective abdominal surgery for malignant disease, including, but not limited to: Esophageal, gastric, colorectal, hepatic, pancreatic, gynecological and urological surgical procedures.\n* Sufficient knowledge of the Dutch language.\n* Communicable and able to assess the questionnaires\n* Written informed consent acquired from the patient.\n\nExclusion Criteria:\n\n* Patients with severe hearing impairment (defined as no or barely verbal communication possible).\n* The patient is expected to be transferred to another hospital postoperatively.\n* Participation in another study that may possibly intervene with the outcome measures. (e.g. in trial use of sleep medication, interventions regarding sleep quality or quantity or similar procedures)\n* Assessment of primary outcome is not possible.\n* Inability or unwillingness to receive the music intervention.\n* Inability to wear the actigraphy device, or inability to perform actigraphy measurement due to paralysis.'}, 'identificationModule': {'nctId': 'NCT06131034', 'acronym': 'DREAMERS', 'briefTitle': 'Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients', 'orgStudyIdInfo': {'id': 'NL78543.078.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music group', 'interventionNames': ['Other: Music']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'description': 'Participant in the intervention group will receive music interventions perioperatively.', 'armGroupLabels': ['Music group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 CN', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'role': 'CONTACT', 'phone': '+31 107040704'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Roos Geensen, MD', 'role': 'CONTACT', 'email': 'r.geensen@erasmusmc.nl', 'phone': '+31 10 7040704'}], 'overallOfficials': [{'name': 'C. Verhoef, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. C. Verhoef', 'investigatorFullName': 'C. Verhoef', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}