Clinical trial NCT04571736: Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform
Official title: Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid
Keywords: Preoperative Procedure
Instructional Films and Video
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.

There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

Detailed description: The objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. For this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups:

* The control group: patients included in this group will receive the usual medical information as part of the surgery performed;
* The experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75,
* Indication of lobo-isthmectomy or total thyroidectomy
* Compliance for the completion of self-questionnaires
* Person affiliated or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Difficulty understanding the French language
* Lack of internet access
* Persons placed under the protection of justice,
* Person under guardianship or curatorship
* Person participating in another research including an exclusion period still in progress,
* Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
* Pregnant / lactating woman

Primary outcomes:
measure: Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
timeFrame: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI-ETAT) SCORE
timeFrame: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
measure: Internet use self-questionnaire
timeFrame: Baseline Day [-90 / -7]
measure: Internet use self-questionnaire
timeFrame: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
measure: specific questionnaire EDOP
timeFrame: post-operative visit Day [5-30] after viewing the screening video
measure: satisfaction assessment questionnaire and understanding of the preoperative medical information for control group
timeFrame: Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
measure: satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe
timeFrame: 2 times at Baseline Day [-90 / -7] before and after the presentation of EDOP platform, Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
measure: State-Trait Anxiety Inventory (STAI-TRAIT) SCORE
timeFrame: Baseline Day[ -90 / -7]
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Gui de Chauliac
state: Hérault
Study officials:
affiliation: University Hospital, Montpellier
name: Cesar Cartier, PI
role: PRINCIPAL_INVESTIGATOR
References: