Description of the Evolution of Functional Dysphonia Managed by Hypnotherapy

NCT05179811 | Terminated

• 1 other identifier: CHH_2021_22
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia.

Conditions

Functional Dystonia (Disorder)

Outcome Measures

Primary Outcomes (1)

• Evolution of perceived voice related disability before and after 3 standardized hypnosis sessions

  Description of this evolution using the Voice Handicap Index score VHI.The questionnaire items were grouped into three equal parts which represent three aspects of voice disorders: functional, emotional and physical. The Voice Handicap Index consists of 30 items, or 10 items per game. The questionnaire is completed item by item by choosing one of the following five answers according to frequency: never, almost never, sometimes, almost always and always.The scores assigned to the answers range from zero to four points, knowing that never is zero and always is worth. The average of the total score at VHI obtained by so called normal subjects, without voice disturbance, is 6.86. A subject obtaining a score equal or less than 6.86 does not present a vocal handicap. A score greater than or equal to 26.62 is pathological

  day 0 and 3 months after last hypnosis session

Study Arms (1)

Cohort

Patients with functional dysphonia using the Voice Handicap Index score.

Procedure: Hypnosis sessions

Interventions

Hypnosis sessions PROCEDURE

* Physical examination * Psychiatric Assessment * VHI, SF-36, IPQ-R questionnaires * Standardized voice recording * 3 Standardized Hypnotherapy sessions * CGI-I-Patient Questionnaire

Cohort

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with functional dysphonia using the Voice Handicap Index score

You may qualify if:

• Diagnosis of functional neurological disorder according to the DSM-5
• Supported at the Rothschild Foundation as part of a hypnotherapy protocol
• Mastering the understanding of the French language
• Express consent to participate in the study

You may not qualify if:

• Organic etiology of dysphonia
• Decompensation of a psychiatric pathology
• Discovery during study of an organic etiology not initially identified

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location

Study Officials

• Cécile HUBSCH

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

• Stéphane MOUCHABAC

  Hôpital Saint-Antoine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: January 5, 2022
• Study Start: April 8, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)