Pre-operative Counselling in Laryngectomized Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04491487

Enrollment

Registered

2020-07-29

Start date

2020-09-01

Completion date

2021-04-01

Last updated

2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Laryngectomy

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.

Interventions

OTHERpre-operative counselling

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Impact of Event Scale-revised	Between the fifth and seventh post-operative day (T0)	presence of post-traumatic symptoms

Secondary

Measure	Time frame	Description
Psychological Distress Inventory	Between the fifth and seventh post-operative day (T0)	psychological distress levels
Hospital Anxiety and Depression Scale	Between the fifth and seventh post-operative day (T0)	anxiety and depression levels

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026