Pre-operative Counselling in Laryngectomized Patients

Total Laryngectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491487
• Other study ID #: 3347
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 1, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Event Scale-revised	presence of post-traumatic symptoms	Between the fifth and seventh post-operative day (T0)
Primary	Impact of Event Scale-revised	presence of post-traumatic symptoms	one month after being discharged from hospital (T1)
Primary	Impact of Event Scale-revised	presence of post-traumatic symptoms	three months after being discharged from hospital (T2)
Secondary	Psychological Distress Inventory	psychological distress levels	Between the fifth and seventh post-operative day (T0)
Secondary	Psychological Distress Inventory	psychological distress levels	one month after being discharged from hospital (T1)
Secondary	Psychological Distress Inventory	psychological distress levels	three months after being discharged from hospital (T2)
Secondary	Hospital Anxiety and Depression Scale	anxiety and depression levels	Between the fifth and seventh post-operative day (T0)
Secondary	Hospital Anxiety and Depression Scale	anxiety and depression levels	one month after being discharged from hospital (T1)
Secondary	Hospital Anxiety and Depression Scale	anxiety and depression levels	three months after being discharged from hospital (T2)