Pre-operative Counselling in Laryngectomized Patients

NCT04491487 | Completed

• 1 other identifier: 3347
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Laryngectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Psychological Distress Inventory

  Between the fifth and seventh post-operative day (T0)

• Psychological Distress Inventory

  one month after being discharged from hospital (T1)

• Psychological Distress Inventory

  three months after being discharged from hospital (T2)

• Hospital Anxiety and Depression Scale

  Between the fifth and seventh post-operative day (T0)

• Hospital Anxiety and Depression Scale

  one month after being discharged from hospital (T1)

Study Arms (2)

Experimental group

EXPERIMENTAL

Other: pre-operative counselling

Control group

NO INTERVENTION

Interventions

pre-operative counselling OTHER

pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years and over;
• patients waiting for TL and primary TEP;
• patients able and willing to provide written informed consent.

You may not qualify if:

• positive history for psychiatric or psychological disorders,
• neurological disorders,
• ineligibility for voice prosthesis rehabilitation.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, 00168, Italy

Location

Study Officials

• Longobardi

  Otolaryngology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 29, 2020
• Study Start: September 1, 2020
• Primary Completion: February 2, 2021
• Study Completion: April 1, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)