Effect of a Music Intervention in Reducing Distress and Pain in Patients With Lung Cancer Undergoing Mini-invasive Surgery

November 14, 2025 updated by: Oncology Institute of Southern Switzerland

Effect of a Music Intervention in Reducing Distress and Pain in Patients With Suspected or Diagnosed Lung Cancer Undergoing Mini-Invasive Surgery

This study aims at evaluating whether music therapy intervention is effective in decreasing psychological (distress) and physical symptoms (pain) in patients with suspected or diagnosed lung cancer undergoing minimally invasive lung surgery.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

A diagnosis of cancer may result in extensive emotional, physical and social suffering. Moreover, surgical treatment of lung cancer represents itself a stressful event. It is important that cancer care incorporates services that help meet patients' psychological, social and spiritual needs. Music therapy interventions have been used to alleviate symptoms and treatment side effects in cancer patients and their efficacy has been demonstrated in various settings. Within the distinction between music therapy (a personalized approach based on the interaction with a trained music therapist) and music medicine (with pre-recorded music), the best efficacy results have been reported with music therapy.

The use of music listening is growing in the field of music therapy intervention because of the impact musical contents can have on physiological, psychological and behavioural levels.

The primary objective of this study is to evaluate whether music therapy intervention is effective in decreasing psychological (distress) and physical symptoms (pain) in patients with suspected or diagnosed lung cancer undergoing minimally invasive lung surgery. Secondary objectives are the evaluation of the decrease of the serum cortisol as biomarker of stress and the request of additional doses of analgesics for pain control.

Study Type

Interventional

Enrollment (Estimated)

74

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

Study Contact Backup

Study Locations

    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Oncology Institute of Southern Switzerland (IOSI)
        • Contact:
        • Contact:

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:

  • Suspected or confirmed diagnosis of lung cancer
  • Age ≥ 18 years
  • Indication for lung resection through a minimally invasive surgery
  • Signed written informed consent

Exclusion Criteria:

  • Endocrinological disorders involving cortisol axis
  • Chronic steroid intake > 10 mg/day
  • Concomitant treatment with drugs against symptomatic anxiety and/or depression
  • Partial or complete hearing loss
  • Inability to follow the schedule of investigation
  • Patient unwilling to refrain from actively listening to other music (e.g., via other personal devices/headphones) outside of the prescribed musical intervention defined by the study protocol during the hospitalization.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A treated with classical music therapy and standard of care
Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with classical music therapy and standard of care.
Patient randomized to experimental Arm A will receive a classical music therapy intervention throughout the duration of their hospital stay for a minimally invasive lung resection.
No Intervention: Arm B treated with standard of care only
Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with standard of care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of distress
Time Frame: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Change of the level of distress on the Distress thermometer
From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Pain intensity
Time Frame: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Change of pain intensity on the numerical scale
From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum cortisol levels
Time Frame: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Change in the levels of serum cortisol measured in the morning
From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Additional doses of analgesics for pain control
Time Frame: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Number of additional doses of analgesics administered for pain control per day
From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

December 15, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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