Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06778720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-16
First Post:
2025-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pain scores after implementation, as measured by Numerical Rating Scale (NRS)', 'timeFrame': 'Principal investigator will introduce intervention in the preoperative area prior to surgery. Then participant will have scheduled VATS procedure. Then the assessment will take place immediately following the surgery in the PACU.', 'description': 'Measuring pain scores of VATS patients immediately after arrival to PACU. After music therapy is implemented, pain scores will be repeated after 30 minutes to see if there is an improvement of pain due to music implementation. Pain will be measured using the Numerical Rating Scale (NRS) pain assessment tool.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Assessment', 'VATS', 'Music Therapy']}, 'referencesModule': {'references': [{'pmid': '32604430', 'type': 'BACKGROUND', 'citation': 'Zhang QL, Xu N, Huang ST, Lin ZW, Chen LW, Cao H, Chen Q. Music Therapy for Early Postoperative Pain, Anxiety, and Sleep in Patients after Mitral Valve Replacement. Thorac Cardiovasc Surg. 2020 Sep;68(6):498-502. doi: 10.1055/s-0040-1713352. Epub 2020 Jun 30.'}, {'pmid': '25725914', 'type': 'BACKGROUND', 'citation': 'Thaut MH. Music as therapy in early history. Prog Brain Res. 2015;217:143-58. doi: 10.1016/bs.pbr.2014.11.025. Epub 2015 Jan 31.'}, {'pmid': '34725621', 'type': 'BACKGROUND', 'citation': 'Patiyal N, Kalyani V, Mishra R, Kataria N, Sharma S, Parashar A, Kumari P. Effect of Music Therapy on Pain, Anxiety, and Use of Opioids Among Patients Underwent Orthopedic Surgery: A Systematic Review and Meta-Analysis. Cureus. 2021 Sep 29;13(9):e18377. doi: 10.7759/cureus.18377. eCollection 2021 Sep.'}, {'pmid': '31785131', 'type': 'BACKGROUND', 'citation': 'Lin CL, Hwang SL, Jiang P, Hsiung NH. Effect of Music Therapy on Pain After Orthopedic Surgery-A Systematic Review and Meta-Analysis. Pain Pract. 2020 Apr;20(4):422-436. doi: 10.1111/papr.12864. Epub 2020 Jan 9.'}, {'pmid': '34621896', 'type': 'BACKGROUND', 'citation': 'Liang J, Tian X, Yang W. Application of Music Therapy in General Surgical Treatment. Biomed Res Int. 2021 Sep 28;2021:6169183. doi: 10.1155/2021/6169183. eCollection 2021.'}, {'pmid': '37646752', 'type': 'BACKGROUND', 'citation': 'Li G, Yu L, Yang Y, Deng J, Shao L, Zeng C. Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2024 Jan;30(1):37-46. doi: 10.1089/jicm.2022.0803. Epub 2023 Aug 30.'}, {'pmid': '33129705', 'type': 'BACKGROUND', 'citation': 'Laframboise-Otto JM, Horodyski M, Parvataneni HK, Horgas AL. A Randomized Controlled Trial of Music for Pain Relief after Arthroplasty Surgery. Pain Manag Nurs. 2021 Feb;22(1):86-93. doi: 10.1016/j.pmn.2020.09.003. Epub 2020 Oct 28.'}, {'pmid': '31341822', 'type': 'BACKGROUND', 'citation': 'Komann M, Weinmann C, Schwenkglenks M, Meissner W. Non-Pharmacological Methods and Post-Operative Pain Relief: An Observational Study. Anesth Pain Med. 2019 Apr 20;9(2):e84674. doi: 10.5812/aapm.84674. eCollection 2019 Apr.'}, {'pmid': '28452603', 'type': 'BACKGROUND', 'citation': 'Kahloul M, Mhamdi S, Nakhli MS, Sfeyhi AN, Azzaza M, Chaouch A, Naija W. Effects of music therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 Dec;12(1):1260886. doi: 10.1080/19932820.2017.1260886.'}, {'pmid': '32894995', 'type': 'BACKGROUND', 'citation': "Dale VH. The impact of perioperative music on abdominal surgery patients' experience of postoperative pain: A systematic review and meta-analysis. J Perioper Pract. 2021 Jan-Feb;31(1-2):31-43. doi: 10.1177/1750458920943375. Epub 2020 Sep 8."}, {'pmid': '36862891', 'type': 'BACKGROUND', 'citation': 'Choi EK, Baek J, Lee D, Kim DY. Effect on music therapy on quality of recovery and postoperative pain after gynecological laparoscopy. Medicine (Baltimore). 2023 Mar 3;102(9):e33071. doi: 10.1097/MD.0000000000033071.'}, {'pmid': '31789881', 'type': 'BACKGROUND', 'citation': 'Bojorquez GR, Jackson KE, Andrews AK. Music Therapy for Surgical Patients: Approach for Managing Pain and Anxiety. Crit Care Nurs Q. 2020 Jan/Mar;43(1):81-85. doi: 10.1097/CNQ.0000000000000294.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this project is to introduce and implement music therapy as an evidence-based pain management protocol focused on reducing postoperative pain levels among Video-Assisted Thoracoscopic Surgery (VATS) patients in the Post-Anesthesia Care Unit (PACU) of the project site. The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.", 'detailedDescription': "The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older with lung mass diagnosis undergoing VATS\n\nExclusion Criteria:\n\n* Individuals with dementia, neurocognitive disorders, or chronic pain conditions.'}, 'identificationModule': {'nctId': 'NCT06778720', 'briefTitle': 'Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative', 'orgStudyIdInfo': {'id': 'STUDY00003902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Therapy', 'description': 'Participants receive music therapy as an evidence-based pain management practice to reduce pain levels in the PACU after a VATS procedure.', 'interventionNames': ['Behavioral: Music Therapy with over-the ear headphones']}], 'interventions': [{'name': 'Music Therapy with over-the ear headphones', 'type': 'BEHAVIORAL', 'description': 'Eligible patients undergoing VATS procedure can have music therapy as an intervention to reduce pain levels after surgery and improve outcomes.', 'armGroupLabels': ['Music Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Sandra Nahom, MSN, RN', 'role': 'CONTACT', 'email': 'sandra.nahom@cshs.org', 'phone': '310-423-5070'}, {'name': 'Sandra Nahom, MSN, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Sandra Nahom, MSN, RN', 'role': 'CONTACT', 'email': 'sandra.nahom@cshs.org', 'phone': '310-423-5070'}], 'overallOfficials': [{'name': 'Sandra Nahom, MSN, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I do not plan to publish results. This is for a school project.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sandra Nahom', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}