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Enrolling by invitation NCT07176013

Immersive Virtual Reality Meditation in Voice Therapy

No phase Interventional Voice Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voice therapy, Meditation, Virtual Reality.
Who it may be relevant to
Registry conditions: Voice Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immediate and Cumulative Effects of Meditation on Voice Therapy Using Immersive Virtual Reality (IVR)

Overview

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.

Interventions

  • Behavioral Voice therapy
    All patients will receive a course of voice therapy as normal.
  • Behavioral Meditation
    Meditation at the start of each session. (each session is 30 minutes)
  • Device Virtual Reality
    TRIPP application in the Meta Quest 2 Virtual Reality Headset.

Primary outcome measures

  • Maximum Phonation Time (MPT) [Time frame: at each therapy session (approximately 1 week apart over 4 weeks)]
  • Noise-to-Harmonic Ratio (NHR) [Time frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Cepstral Peak Prominence (CPPS) [Time frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Acoustic Vocal Quality Index (AVQI) [Time frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
Secondary outcome measures (7)
  • Voice Handicap Index [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Vocal Fatigue Index [Time frame: 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 [Time frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Heart rate measured in beats per minute [Time frame: Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai Downtown Union Square — New York

Identifiers

NCT: NCT07176013 · STUDY-24-01217

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗