Pre-operative Counselling in Laryngectomized Patients

Not Applicable

Completed

• Conditions: Total Laryngectomy
• Interventions: Other: pre-operative counselling

• Registration Number: NCT04491487
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-25
• Study First Posted: 2020-07-29
• Study Start: 2020-09-01
• Primary Completion: 2021-02-02
• Study Completion: 2021-04-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	pre-operative counselling	-

Primary Outcome Measures

Name	Time	Method
Impact of Event Scale-revised	three months after being discharged from hospital (T2)	presence of post-traumatic symptoms

Secondary Outcome Measures

Name	Time	Method
Psychological Distress Inventory	three months after being discharged from hospital (T2)	psychological distress levels
Hospital Anxiety and Depression Scale	three months after being discharged from hospital (T2)	anxiety and depression levels

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Roma, Italy