- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235098
Effect of a Music Intervention in Reducing Distress and Pain in Patients With Lung Cancer Undergoing Mini-invasive Surgery
Effect of a Music Intervention in Reducing Distress and Pain in Patients With Suspected or Diagnosed Lung Cancer Undergoing Mini-Invasive Surgery
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luigi Tortola, PhD
- Phone Number: +41 91 811 96 68
- Email: luigi.tortola@eoc.ch
Study Contact Backup
- Name: Patrizia Froesch, MD
- Phone Number: +41 91 811 48 40
- Email: patrizia.froesch@eoc.ch
Study Locations
-
-
Canton Ticino
-
Bellinzona, Canton Ticino, Switzerland, 6500
- Oncology Institute of Southern Switzerland (IOSI)
-
Contact:
- Luigi Tortola, PhD
- Phone Number: +41 91 811 96 68
- Email: luigi.tortola@eoc.ch
-
Contact:
- Patrizia Froesch, MD
- Phone Number: +41 91 811 48 40
- Email: patrizia.froesch@eoc.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOSI-MUSICAL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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