Pre-operative Counselling in Laryngectomized Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial

Conditions
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Total Laryngectomy

Intervention / Treatment
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* Other: pre-operative counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years and over; patients waiting for TL and primary TEP; patients able and willing to provide written informed consent. Exclusion Criteria: positive history for psychiatric or psychological disorders, neurological disorders, ineligibility for voice prosthesis rehabilitation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Other: pre-operative counselling<br>* pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale-revised | presence of post-traumatic symptoms | Between the fifth and seventh post-operative day (T0) | 
| Impact of Event Scale-revised | presence of post-traumatic symptoms | one month after being discharged from hospital (T1) | 
| Impact of Event Scale-revised | presence of post-traumatic symptoms | three months after being discharged from hospital (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Distress Inventory | psychological distress levels | Between the fifth and seventh post-operative day (T0) | 
| Psychological Distress Inventory | psychological distress levels | one month after being discharged from hospital (T1) | 
| Psychological Distress Inventory | psychological distress levels | three months after being discharged from hospital (T2) | 
| Hospital Anxiety and Depression Scale | anxiety and depression levels | Between the fifth and seventh post-operative day (T0) | 
| Hospital Anxiety and Depression Scale | anxiety and depression levels | one month after being discharged from hospital (T1) | 
| Hospital Anxiety and Depression Scale | anxiety and depression levels | three months after being discharged from hospital (T2) |