跳至主要内容
临床试验/NCT05519488
NCT05519488招募中不适用

Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients

Rubato Life2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
State-Anxiety (STAI-S)

研究概览

简要总结

Receiving a cancer diagnosis is a life-altering event for patients and their families that not only carries serious physical health implications but also causes significant stress and emotional distress.

After initial diagnosis, restaging appointments can bring back additional fear, sadness, and anxiety. Music listening interventions can alleviate stress associated with cancer diagnosis by improving patients' ability to cope with the mental and emotional strain that accompanies their disease. Yet, current music listening interventions lack personalization and moment-to-moment adjustments that accompany traditional music therapy in the hands of a seasoned professional. Rubato Life™ (RL) application uses a proprietary algorithm for music selection that utilizes machine-learning and deep neural network to select music that reduces stress as measured by heart rate variability in real time, offering improved personalization of stress-reducing music. We hypothesize that using personalized musical playlists, through RL, will improve stress and anxiety outcomes for patients undergoing cancer restaging more than participant-selected music.

This 3-week longitudinal study will include 200 patients from St. Elizabeth's Medical Center who have scheduled appointments for cancer restaging. Participants will be randomized into one of two groups: a) an intervention group, in which patients will listen to music using Rubato Life app, and b) a control group, in which patients listen to music of their own choice that they believe to be stress reducing. Patients in both groups will be asked to listen to at least 45 minutes per day, for a period of 2 weeks coming up to their scheduled restaging appointment (or at least 12 total hours of listening), and for one hour immediately after the appointment. Patients in the Intervention group will wear smartwatches to monitor heart rate variability throughout the study. Patients will be asked to complete assessments of anxiety (STAI-S) prior to randomization, on the day of their restaging, and following one hour of post-restaging music listening.

详细描述

A. Specific Aims/Objectives:

• Primary Aim:

Determine if Rubato Life (RL) music selection is effective at reducing anxiety (STAI-S) in cancer patients undergoing restaging.

B. Background and Significance

The field of music-based interventions (MBI) is growing rapidly as part of the treatment of patients with chronic diseases such as schizophrenia, cardiovascular disease, dementia, chronic pain and cancer (Sihvonen et al., 2017). MBI can be divided into Music Therapy (MT) and Music Medicine (MM).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or older
  • Diagnosed with cancer, requiring restaging imaging between September 2022 and May 2023,
  • Have access to a smartphone and able to operate smartphone
  • Have a Google or Apple ID.

排除标准

  • Participants with hearing disorders who do not use hearing aids
  • Participants who have extreme dislike of music.
  • Participants who cannot comply with the minimum time Rubato Life application requires to be used

结局指标

主要结局

State-Anxiety (STAI-S)

时间窗: 2 weeks

A standardized 20-item assessment of state-level (momentary, situational) anxiety (Spielberger et al., 1999). Example items include "I am tense", "I am worried" and "I feel calm", "I feel secure". STAI has an internal consistency ranging between 0.86 -0.95 and test-retest reliability from 0.65-0.75.

次要结局

未报告次要终点

研究者

发起方
Rubato Life
申办方类型
Other
责任方
Sponsor

研究点 (2)

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