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OpenTrials
Completed

NCT Number: NCT04491487

Pre-operative Counselling in Laryngectomized Patients

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.

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Key information

Conditions

Total Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre-operative counselling

Other

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

Primary outcomes

  1. Impact of Event Scale-revised

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

    presence of post-traumatic symptoms

  2. Impact of Event Scale-revised

    Time frame: one month after being discharged from hospital (T1)

    presence of post-traumatic symptoms

  3. Impact of Event Scale-revised

    Time frame: three months after being discharged from hospital (T2)

    presence of post-traumatic symptoms

Secondary outcomes

  1. Psychological Distress Inventory

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

    psychological distress levels

  2. Psychological Distress Inventory

    Time frame: one month after being discharged from hospital (T1)

    psychological distress levels

  3. Psychological Distress Inventory

    Time frame: three months after being discharged from hospital (T2)

    psychological distress levels

  4. Hospital Anxiety and Depression Scale

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

    anxiety and depression levels

  5. Hospital Anxiety and Depression Scale

    Time frame: one month after being discharged from hospital (T1)

    anxiety and depression levels

  6. Hospital Anxiety and Depression Scale

    Time frame: three months after being discharged from hospital (T2)

    anxiety and depression levels

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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