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临床试验/NCT06172959
NCT06172959招募中不适用

The Short-term Impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on Respiratory Function in Patients With Lung Cancer

University of Miami2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
3
试验地点
2
主要终点
Change in Dyspnea measured by Modified Borg Scale

研究概览

简要总结

The purpose of this study is to examine the short-term impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on respiratory function in patients with lung cancer. As a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will include three patients diagnosed with lung cancer, stages I-III, who have undergone a thoracentesis or thoracotomy in the last 12 months. Thoracic surgical procedures include pulmonary lobectomy or cancer-related surgical procedure (e.g., pneumonectomy). This diagnosis must be made by the patient's oncologist and medical team.
  • The age range will be 40 to 80 years old. Both female and male participants from any race and ethnicity will be included in the study.
  • The study will include English and Spanish speakers only.
  • Patients must have less than five years of voice training experience (e.g., choir, private voice lessons).

排除标准

  • Patients in respiratory failure
  • Individuals with severe neurological and hearing impairments.
  • Patients with diagnosed dysphonia and individuals who have undergone a laryngectomy
  • Participants that do not have access to an electronic device, either an iPad, tablet, or laptop, as well as reliable internet access. They will also need to have adequate knowledge of technology or participate with a caregiver who knows how to navigate Zoom.
  • Participants who do not have access to a quiet space. Headphones are optional for this study.
  • Prisoners
  • Persons under the age of 40 or over the age of 80.

研究组 & 干预措施

Vocal Therapy Group

Experimental

Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks

干预措施: Vocal Intonation Therapy (VIT) (Behavioral)

Vocal Therapy Group

Experimental

Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks

干预措施: Therapeutic Singing (TS) (Behavioral)

结局指标

主要结局

Change in Dyspnea measured by Modified Borg Scale

时间窗: Baseline, up to 30-minutes (Post-Intervention)

Scores change from 0 to 10. Higher scores suggest more severity in shortness of breath

Change in Respiratory Quality of Life measured by St.Georges Respiratory Questionnaire

时间窗: Baseline, up to 1 month

A composite score will be obtained, ranging from 0 to 100. Higher scores indicate worst respiratory quality of life

Change in Maximum Phonation Time (MPT) in seconds

时间窗: Baseline, up to 30-minutes (Post-Intervention)

Maximum Phonation Time (MPT) measures the number of seconds a participant can sustain a phonated sound.

Respiratory Rate

时间窗: Up to 30-minutes

Measured by the number of breaths per minute

Change in Dyspnea measured by Cancer Dyspnea Scale

时间窗: Baseline, up to 1 month

Scores range from 1 (Not at all) to 5 (Very much). Higher scores suggest more severity of dyspnea

Change in Dyspnea measured by Dyspnea-12 Questionnaire

时间窗: Baseline, up to 1 month

Scores range from 0 to 3. Higher scores suggest more severity in shortness of breath

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Lesiuk

Professor

University of Miami

研究点 (2)

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