Pre-operative Counselling in Laryngectomized Patients

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Total Laryngectomy

Treatments: Other: pre-operative counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04491487

3347

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Other: pre-operative counselling

Control group

No Intervention group