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Recruiting NCT07235098

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

No phase Interventional Lung Cancer (Suspected or Confirmed)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music therapy intervention.
Who it may be relevant to
Registry conditions: Lung Cancer (Suspected or Confirmed). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Music therapy intervention
    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.

Primary outcome measures

  • Level of distress [Time frame: 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)]
Secondary outcome measures (2)
  • Serum cortisol levels [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Switzerland · 1 center
  • Oncology Institute of Southern Switzerland (IOSI) — Bellinzona

Identifiers

NCT: NCT07235098 · IOSI-MUSICAL-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗