Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations

Thyroid Nodule Clinical Trial

Official title:

Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342739
• Other study ID #: IEO 1595
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +390257489731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules.

Description:

Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. Endocrinologist and/or surgeon and/or radiologist involved in the consultation will be recruited as well. Before the scheduled consultation with endocrinologist, surgeon or radiologist, benign thyroid nodules patients will be screened for eligibility by a researcher and a physician from the Interventional Radiology Unit. If patients meet all the inclusion criteria, they will be contacted by the researcher and proposed to participate. The day of the consultations, researcher will meet participants face to face, they will answer any questions should arise and will ask them to sign the informed consent form. Benign thyroid nodules patients have a specific clinical pathway, in which they may have consultations with endocrinologists, and/or with surgeon, and/or with radiologists. Patients will be recruited before their first consultation and then, if they are scheduled to have other consultations with other professionals, will be recruited as well for the following consultations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Specifically, to be eligible for the inclusion in this study, each patient has to fulfill

all these criteria:

• diagnosis of benign thyroid nodule;
• scheduled consultation with endocrinologist and/or surgeon and/or radiologist to discuss treatment options related to benign thyroid nodule;
• =18 years old at the time of recruitment;
• proper understanding of Italian language;
• fluent Italian speaker;
• able to comply to requested procedures to obtain audio-video recording.

Each professional has to fulfill these criteria:

• proper understanding of Italian language;
• fluent Italian speaker;
• able to comply to requested procedures to obtain audio-video recording.

Exclusion Criteria:

• Patients with diagnosed mental or neurological disorder that could impair the participation will be excluded from the study.

Related Conditions & MeSH terms

• Thyroid Nodule

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction	The primary endpoint of our research is to test the predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction with tha analysis of audio and video recording file.; Variables analyzed from audio recording will be use of words, verbal synchrony, empathic communication; variables analyzed from video recording will be facial emotion expression and facial emotion expression synchrony	1 month