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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Level of distress [Срок оценки: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)]
• Pain intensity [Срок оценки: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)]

Вторичные конечные точки (2)

• Serum cortisol levels [Срок оценки: 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 [Срок оценки: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Oncology Institute of Southern Switzerland (IOSI) — Bellinzona

Идентификаторы

NCT: NCT07235098 · IOSI-MUSICAL-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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