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RecruitingNCT04571736AMEDOPUpdated Jun 22, 2026

Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform

An interventional study of access to the internet information platform in Thyroid, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Nov 2020; still recruiting 5 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Thyroid

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Keywords

  • Preoperative Procedure
  • Instructional Films and Video
03

In context

Thyroid Diseases

365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.

This study's planned enrollment of 220 is above the median of 88 across 198 interventional studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    access to the internet information platform

    usual preoperative information and access to the internet information platform

    Other: access to the internet information platform

  • No intervention
    usual preoperative information

    medical information delivered to the patient before any surgery

Interventions

  • Otheraccess to the internet information platform

    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.

06

What researchers measure

Primary outcomes

  1. Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE

    rate of patients with perioperative anxiety symptoms refind by APAIS SCORE \>= 11. Rate from 1 (absent) to 5 (extrem). Score 2 to 4 : rejection of information, 5 to 7 : medium desire for information, \> 7 : hungry for information.

    Time frame: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI-ETAT) SCORE

    overall anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.

    Time frame: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]

  2. Internet use self-questionnaire

    Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during the inclusion visit. 4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3. Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no. Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no. Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).

    Time frame: Baseline Day [-90 / -7]

  3. Internet use self-questionnaire

    Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during post opérative visit. 4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3. Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no. Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no. Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).

    Time frame: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]

  4. specific questionnaire EDOP

    specific questionnaire in experimental group on the internet platform. 6 Items. Items 1, 2, 3, 6 in the form of a 5-response Likert scale (from 1: not satisfied at all, to 5 very satisfied). Item 4 number of times the platform is consulted. Item 5 is if the subject had consulted other website after consulting EDOP platform. If yes how many times, and the name(s) of the website, why did you consult website.

    Time frame: post-operative visit Day [5-30] after viewing the screening video

  5. satisfaction assessment questionnaire and understanding of the preoperative medical information for control group

    Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for the control group. 4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally). Item 2 necessity of complementary information, choice between no, a few, many information. Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally). Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.

    Time frame: Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]

  6. satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe

    Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for experimental groupe before and after the presentation of the EDOP plateform. 4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally). Item 2 necessity of complementary information, choice between no, a few, many information. Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally). Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.

    Time frame: 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]

  7. State-Trait Anxiety Inventory (STAI-TRAIT) SCORE

    trait anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.

    Time frame: Baseline Day[ -90 / -7]

07

Study locations

1 of 1 sites recruiting
  • CHU Gui de Chauliac
    Montpellier, Hérault 34295, France
    Recruiting
    • Susana LEONARD, CRA · Contacts-leonard@chu-montpellier.fr · 04 67 33 61 56
    • Cesar Cartier, PI · Principal investigator
    • Thibault Kennel, sub- PI · Sub investigator
    • Agnes Viquesnel, sub-PI · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04571736
Responsible party
Sponsor
First posted
Oct 1, 2020
Start date
Nov 18, 2020
Primary completion
Nov 18, 2026 (estimated)
Completion
Mar 18, 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Cesar Cartier, PI
Contact
c-cartier@chu-montpellier.fr
0467336895 ext. +33
Susana Leornard, CRA
Contact
s-leonard@chu-montpellier.fr
04 67 33 61 56 ext. +33
Cesar Cartier, PI
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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