Speech Therapy and Functional Dysphonia After Thyroidectomy

NCT ID: NCT05963178

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort

Group Type: EXPERIMENTAL

Pre-operative counselling

Intervention Type: 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.

Interventions

Pre-operative counselling

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Early speech therapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

LONGOBARDI YLENIA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ylenia Longobardi, SLP

Role: CONTACT

ylenia.longobardi@policlinicogemelli.it

0630155193 ext. +39

Facility Contacts

Ylenia Longobardi, SLP

Role: primary

ylenia.longobardi@policlinicogemelli.it

0630155193 ext. +39

Other Identifiers

5604

Identifier Type: -

Identifier Source: org_study_id