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Clinical Trial Summary

The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice. This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04491487
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Completed
Phase N/A
Start date September 1, 2020
Completion date April 1, 2021

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