Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and a Relevant Mediator

Официальное название

The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator

Обзор

The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.

Подробное описание

To assess the protocol, recruited participants will be randomly allocated into two groups: a control group or a music therapy group. Participants in the control group will receive standard care as usual, and they will be offered music therapy interventions upon their request during subsequent appointments. Participants in the music group will receive standard care and music therapy interventions. All participants will rate their psychological states pre- and post-MRI exams. Their physiological data will be recorded during the examination. After the scanning, they will complete an experience review.

Вмешательства

• Другое Music therapy
  The intervention has two parts. The first part is an approximately 15-minute music therapy session to induce relaxation and positive memories attached to the relaxing live music provided by a credentialed music therapist. The second part is music listening during the scanning process.

Первичные конечные точки

• Anxiety [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days]
• Symptom distress [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days]
• Relaxation [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days]

Вторичные конечные точки (5)

• Pulse rates [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 day]
• Respiration rate [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
• Scanning efficiency [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
• Patient satisfaction level [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days]
• Patient attention to music (only for the music therapy group) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days]

Критерии участия

Критерии включения

• The subject is diagnosed with cancer;
• The subject is between 18- 60 years old;
• The subject understands Mandarin, Cantonese, or English;
• The subject did not use medication for sedatives, anxiolytics, and/or sleep aids;
• The subject is awake without cognitive disorders;
• the subject rates more than 0 on the 0-10 VAS for anxiety;
• The subject has finished primary school level education.

Критерии исключения

• The subject withdraws the MRI scan;
• The subject needs other intervention(s) to complete the scan;
• The subject has hearing and/or visual impairments;
• The subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders.

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• GuangZhou Concord Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06282887 · 2021-IIT-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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