Improvement of the Phonatory Outcome in Patients Undergoing Open Partial Horizontal Laryngectomy (OPHL) and Speech Therapy by Applying the Bruni® Training: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Maximum phonation time
研究概览
简要总结
Surgically treated patients with type II OPHL being treated at the Phoniatrics Unit of the Fondazione Policlinico Universitario A. Gemelli-IRCCS, but not satisfied with their voice after the first cycle of therapy with a standard rehabilitation approach, will be recruited. To interested patients, a specific vocal rehabilitation program based on Bruni training will be proposed in order to compare the results obtained using this method with those following the previous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18;
- •Italian mother tongue;
- •ability to produce the replacement voice;
- •ability to provide written informed consent
排除标准
- •< 1 year from the end of both surgical and radiotherapy treatment;
- •presence of disease recurrence;
- •sensory, neurological deficits
- •Learning disabilities
结局指标
主要结局
Maximum phonation time
时间窗: 3 months
emit a sustained /a/ for as long as possible with a single air intake. The test will be repeated three times and the longest of the three attempts will be calculated as MPT
type of spectrogram
时间窗: 3 months
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
foundamental frequency
时间窗: 3 months
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
Formantic peaks
时间窗: 3 months
The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
perceptual evaluation
时间窗: 3 months
Voices will be perceptually rated by expert clinicians using the INFVo scale which includes overall impression (I), amount of unintentional additive noise (N), fluency (F) and voice quality (Vo). For each parameter the score can vary from 0 to 10. The higher the score, the better the perceived voice quality.
self evaluation of voice
时间窗: 3 months
Patients will be administered the self-evaluation questionnaire "Self-evaluation of Communicative Experience after Laryngeal cancer" which measures adaptation to the replacement voice through 35 items in three subscales (General, Environment, Attitude). Patients should rate each statement on a 4-point categorical scale. You can get a total score from 0 to 102 and three subscores. A score ≥60 suggests the need for specific psychological intervention for acceptance of the new voice.
次要结局
未报告次要终点
研究者
LONGOBARDI YLENIA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS