Pre-operative Counselling in Laryngectomized Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Total Laryngectomy
• Intervention / Treatment: Other: pre-operative counselling

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A.Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Longobardi, Otolaryngology department

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 3347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No