- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06778720
Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative
January 12, 2025 updated by: Sandra Nahom, Cedars-Sinai Medical Center
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sandra Nahom, MSN, RN
- Phone Number: 310-423-5070
- Email: sandra.nahom@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
Contact:
- Sandra Nahom, MSN, RN
- Phone Number: 310-423-5070
- Email: sandra.nahom@cshs.org
-
Principal Investigator:
- Sandra Nahom, MSN, RN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18 years and older with lung mass diagnosis undergoing VATS
Exclusion Criteria:
- Individuals with dementia, neurocognitive disorders, or chronic pain conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy
Participants receive music therapy as an evidence-based pain management practice to reduce pain levels in the PACU after a VATS procedure.
|
Eligible patients undergoing VATS procedure can have music therapy as an intervention to reduce pain levels after surgery and improve outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in pain scores after implementation, as measured by Numerical Rating Scale (NRS)
Time Frame: 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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra Nahom, MSN, RN, Cedars-Sinai Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 14, 2025
Primary Completion (Estimated)
March 10, 2025
Study Completion (Estimated)
March 10, 2025
Study Registration Dates
First Submitted
January 9, 2025
First Submitted That Met QC Criteria
January 12, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 12, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00003902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I do not plan to publish results.
This is for a school project.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on VATS
-
Brigham and Women's HospitalUnknownLung Nodule | VATS Lobectomy | VATS Segmentectomy | Care PathwayUnited States
-
University of UtahWithdrawnVideo-assisted Thoracic Surgery (VATS)United States
-
Taipei Medical University WanFang HospitalUnknownEfficacy and Safety of VATS Block
-
Firat UniversityRecruitingApplying SPSIP Block With Ultrasound Guidance After VATS | Applying SAP Block With Ultrasound Guidance After VATS | Comparing the Effectiveness of Blocks Using Postoperative NRS Pain ScoresTurkey (Türkiye)
-
Institut Mutualiste MontsourisUnknownSegmentectomy | Video-assisted Thoracoscopic Surgery (VATS)France
-
Ain Shams UniversityRecruitingVideo Assisted Thoracic Surgery (VATS)Egypt
-
Ataturk UniversityCompletedVATS | Video Assisted Thoracoscopic SurgeryTurkey (Türkiye)
-
Bursa City HospitalUlusoy, Emre, M.D.RecruitingPostoperative Pain Management | Video-assisted Thoracoscopic Surgery (VATS)Turkey (Türkiye)
-
Hospital DonostiaCompletedErector Spinae Plane Block | Regional Anaesthesia | Video Assisted Thoracic Surgery (VATS) | ERAS ProgrammesSpain
-
Cairo UniversityRecruitingVATS | Post-operative Analgesia | Retrolaminar Block | Erector Spinae Plan BlockEgypt
Clinical Trials on Music Therapy with over-the ear headphones
-
Dr. Tamsin BrownCompleted
-
University of California, San FranciscoTerminatedMusic Therapy for Pain and SedationUnited States
-
Medical University of WarsawRecruitingDental Anxiety | Music Therapy | Oral Surgical ProceduresPoland
-
Children's HealthCompletedAutism Spectrum DisorderUnited States
-
Hasan SARITAŞCompletedSurgical Stress ResponseTurkey
-
Ankara City Hospital BilkentCompletedPostoperative Pain | Anxiety | Anesthesia | Postoperative RecoveryTurkey
-
University of San FranciscoFulbrightCompletedAnxiety | Acute Pain | Self EfficacyIceland
-
Cedars-Sinai Medical CenterNot yet recruitingPostoperative Pain | Shoulder PainUnited States
-
University of LouisvilleCompleted
-
US Department of Veterans AffairsCompletedPost-Traumatic Stress DisorderUnited States