Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2020-09-01
2021-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Experimental group
pre-operative counselling
pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy
Control group
No interventions assigned to this group
Interventions
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pre-operative counselling
pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy
Eligibility Criteria
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Inclusion Criteria
* patients waiting for TL and primary TEP;
* patients able and willing to provide written informed consent.
Exclusion Criteria
* neurological disorders,
* ineligibility for voice prosthesis rehabilitation.
18 Years
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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LONGOBARDI YLENIA
researcher
Principal Investigators
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Longobardi
Role: PRINCIPAL_INVESTIGATOR
Otolaryngology department
Locations
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Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma, , Italy
Countries
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Other Identifiers
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3347
Identifier Type: -
Identifier Source: org_study_id
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