Speech Therapy and Functional Dysphonia After Thyroidectomy

NCT05963178 | Unknown DMC

• 1 other identifier: 5604
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Following a thyroidectomy, voice and swallowing alterations, which more frequently would appear to be caused by lesions of the laryngeal nerve, may occur. But, voice and swallowing changes can also occur in the absence of lesions of the inferior laryngeal nerve or the external branch of the superior laryngeal nerve, defining a condition called central compartment syndrome or functional post-thyroidectomy syndrome. It has been demonstrated that, in the presence of the aforementioned syndrome, the quality of the voice undergoes a deterioration immediately after thyroidectomy surgery with a lowering of pitch. The purpose of this study will be to verify the effects of early speech therapy, including pre-operative speech therapy counseling (during which the patient will be provided with indications to be implemented in the immediate post-operative period).

Conditions

Functional Dysphonia

Outcome Measures

Primary Outcomes (8)

• Acoustic analysis (f0)

  Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.

  3 months

• Acoustic analysis (NHR)

  Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.

  3 months

• Acoustic analysis (Jitter%)

  Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.

  3 months

• Acoustic analysis (Shimmer%)

  Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.

  3 months

• Voice Range Profile (Flow)

  The patient will be instructed in the production of a sustained /a/ from the lowest to the highest note, from minimum to maximum intensity. In this case, the Minimum frequency (Flow) will be analysed.

  3 months

• Voice Range Profile (Fhigh)

  The patient will be instructed in the production of a sustained /a/ from the lowest to the highest note, from minimum to maximum intensity. In this case, the Maximum frequency (Fhigh) will be analysed.

  3 months

• Voice function

  A questionnaire called Voice Impairment Score (VIS) will be used, created specifically to investigate the frequency of voice alterations. The VIS consists of 10 items and can vary from a minimum score of 0 (no vocal alteration) to a maximum of 40 (maximum voice disturbance).

  3 months

• Swallowing function

  A questionnaire called Swallowing Impariment Scores (SIS) will be used, created specifically to investigate the frequency of swallowing alterations. The SIS consists of 5 items and can vary from a minimum score of 0 (no vocal alteration) to a maximum of 20 (maximum swallowing disturbance).

  3 months

Study Arms (1)

Cohort

EXPERIMENTAL

Behavioral: Pre-operative counselling

Interventions

Pre-operative counselling BEHAVIORAL

A preoperative speech therapy counseling will be carried out the day before the Total Thyroidectomy with the aim of informing patients about the possible conditions of the immediate post-operative period. Therefore, indications of vocal hygiene and hydration standards will be simultaneously administered, to be implemented from the first post-operative day. Patients will undergo phoniatric follow-up in the immediate post-operative period, at 7 days, 1 month and 3 months post-operatively. Patients who, at follow-up checks, should present the symptoms of functional post-thyroidectomy syndrome will undergo a cycle of post-operative speech therapy of 8 sessions.

Also known as: Early speech therapy

Cohort

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• awaiting Total Thyroidectomy surgery
• able to sign a written consent

You may not qualify if:

• Under the age of 21 or over the age of 65
• Previous vocal cord paralysis
• History of vocal or laryngeal pathologies that have required therapy
• Presence of speech disorders or lung pathologies
• Previous neck surgery
• Presence of malignant diseases

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, 00168, Italy

RECRUITING

Central Study Contacts

Ylenia Longobardi, SLP

CONTACT

0630155193; ylenia.longobardi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 27, 2023
• Study Start: July 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)