Immediate and Cumulative Effects of Meditation on Voice Therapy Using Immersive Virtual Reality (IVR)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Phonation Time (MPT)
研究概览
简要总结
This study aims to explore the feasibility of incorporating regular guided meditations via immersive virtual reality (IVR) at the start of voice therapy sessions to facilitate better learning and retention of treatment. The study will involve 30 participants, and use the TRIPP application with the Meta Quest 2 virtual reality headset, known for its immersive meditation experiences designed to calm or focus the user. The objective is to investigate the immediate effects of meditation/mindfulness in IVR on vocal production, with the goal of improving self-regulation, attentional focus, and reducing vocal hyperfunction. IVR has been utilized in mental health settings and exposure therapy for various conditions, but its application in voice therapy, particularly for anxiety reduction through fully immersive meditation, remains unexplored. The study seeks to determine whether IVR can enhance therapy outcomes by improving engagement, attention, and vocal control in individuals undergoing voice therapy, potentially maximizing treatment gains. Through this research, the aim is to assess the efficacy of IVR in enhancing voice therapy interventions and addressing the unique challenges posed by stress and anxiety in voice users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with voice disorders, difficulties or laryngeal hypersensitivity, and who also have anxiety
- •Must have availability to participate for entire course of 5 consistent weeks
排除标准
- •Anyone not meeting inclusion criteria
- •Presence of any additional medical condition significantly affecting:
- •Respiratory function (e.g., advanced lung disease)
- •Laryngeal function (e.g., status-post deep brain stimulation)
- •Lingual function
- •Velopharyngeal function (e.g., laryngectomy)
研究组 & 干预措施
Meditation with VR
Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
干预措施: Voice therapy (Behavioral)
Meditation with VR
Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
干预措施: Meditation (Behavioral)
Meditation with VR
Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
干预措施: Virtual Reality (Device)
Meditation without VR
Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.
干预措施: Voice therapy (Behavioral)
Meditation without VR
Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.
干预措施: Meditation (Behavioral)
No Meditation
Those who receive standard voice therapy with no meditation.
干预措施: Voice therapy (Behavioral)
结局指标
主要结局
Maximum Phonation Time (MPT)
时间窗: at each therapy session (approximately 1 week apart over 4 weeks)
MPT will be used to assess participants' maximum phonation time. The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible. The task is performed twice, and the maximum duration of the two measurements is used.
Noise-to-Harmonic Ratio (NHR)
时间窗: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value.
Cepstral Peak Prominence (CPPS)
时间窗: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. An increase in CPPS value indicates an improvement in voice symptoms.
Acoustic Vocal Quality Index (AVQI)
时间窗: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
The acoustic voice quality index (AVQI) is a multiparametric score to quantify vocal quality. It is based on a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. A lower score correlates with a better vocal quality.
次要结局
- Voice Handicap Index(Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session)
- State Trait Anxiety Inventory Y-1 (STAI-1), long form(Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session)
- State Trait Anxiety Inventory Y-1 (STAY Y-1), short form(Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks)
- State Trait Anxiety Inventory Y-2 (STAI Y-2), long form(Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session)
- Vocal Fatigue Index(Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session)
- CAPE-V, Consensus on Auditory-Perceptual Evaluation of Voice(Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session)
- Heart rate measured in beats per minute(Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks)
研究者
Bradley Hoff
Speech-Language Pathologist
Icahn School of Medicine at Mount Sinai