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Pain AssessmentNCT06778720

Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative

A study testing Music Therapy with over-the ear headphones in people with Pain Assessment and VATS, run by Cedars-Sinai Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain Assessment, VATS, Music Therapy
What is being tested?
Music Therapy with over-the ear headphones
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Jan 2025to 10 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years and older with lung mass diagnosis undergoing VATS

Who cannot join

  • Individuals with dementia, neurocognitive disorders, or chronic pain conditions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Nahom, MSN, RN contact

310-423-5070

sandra.nahom@cshs.org

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Sandra Nahom, MSN, RN, 310-423-5070, sandra.nahom@cshs.org

    Sandra Nahom, MSN, RN

Other trials in United States

About this study

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.

Read the 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.

Being tested
Music Therapy with over-the ear headphones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music Therapy with over-the ear headphonesBehavioural

    Eligible patients undergoing VATS procedure can have music therapy as an intervention to reduce pain levels after surgery and improve outcomes.

Study groups in NCT06778720
Study groupRoleWhat they receive
Music TherapyExperimentalParticipants receive music therapy as an evidence-based pain management practice to reduce pain levels in the PACU after a VATS procedure.
Receives: Behavioral: Music Therapy with over-the ear headphones

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in pain scores after implementation, as measured by Numerical Rating Scale (NRS)

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start14 Jan 2025 (estimated)
  3. Primary completion10 Mar 2025 (estimated)
  4. Study completion10 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06778720
Sponsor's protocol ID
STUDY00003902
Status last verified
Jan 2025
First submitted
9 Jan 2025
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I do not plan to publish results. This is for a school project.

Publications

  • 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.

    PubMed 32604430

  • 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.

    PubMed 25725914

  • 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.

    PubMed 34725621

  • 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.

    PubMed 31785131

  • 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.

    PubMed 34621896

  • 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.

    PubMed 37646752

  • 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.

    PubMed 33129705

  • 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.

    PubMed 31341822

  • 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.

    PubMed 28452603

  • 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.

    PubMed 32894995

  • 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.

    PubMed 36862891

  • 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.

    PubMed 31789881

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy with over-the ear headphones in people with Pain Assessment and VATS, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra Nahom, MSN, RN (310-423-5070, sandra.nahom@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778720, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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