ThyroidAMEDOPNCT04571736
Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform
A study testing access to the internet information platform in people with Thyroid, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid
- What is being tested?
- access to the internet information platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2020to 18 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Gui de Chauliac
Montpellier, Hérault, 34295
Susana LEONARD, CRA, 04 67 33 61 56 ext. +33, s-leonard@chu-montpellier.fr
Cesar Cartier, PI
About this study
Official title: Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
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.
- Conditions
- Thyroid
- Being tested
- access to the internet information platform
- Keywords
- Preoperative Procedure, Instructional Films and Video
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
access to the internet information platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| access to the internet information platform | Active comparator | usual preoperative information and access to the internet information platform Receives: Other: access to the internet information platform |
| usual preoperative information | No intervention | medical information delivered to the patient before any surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]
Secondary outcomes (7)
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.
Measured: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
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).
Measured: Baseline Day [-90 / -7]
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).
Measured: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
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.
Measured: post-operative visit Day [5-30] after viewing the screening video
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.
Measured: Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
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.
Measured: 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]
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.
Measured: Baseline Day[ -90 / -7]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start18 Nov 2020
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesar Cartier, PI, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571736
- Sponsor's protocol ID
- RECHMPL19_0085 (7782)
- Other IDs
- 2019-A02241-56
- Acronym
- AMEDOP
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
- ClinicalTrials.gov ID
- NCT04571736
- Acronym / sponsor ID
- AMEDOP / RECHMPL19_0085 (7782)
- Conditions
- Thyroid
- Keywords
- Preoperative Procedure, Instructional Films and Video
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| access to the internet information platform | Active comparator | Other: access to the internet information platformusual preoperative information and access to the internet information platform |
| usual preoperative information | No intervention | –medical information delivered to the patient before any surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| access to the internet information platformThis 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. | Other | access to the internet information platform |
Primary outcome
Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
Time frame: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]
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.
7 secondary outcomes
State-Trait Anxiety Inventory (STAI-ETAT) SCORE
Time frame: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
Internet use self-questionnaire
Time frame: Baseline Day [-90 / -7]
Internet use self-questionnaire
Time frame: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
specific questionnaire EDOP
Time frame: post-operative visit Day [5-30] after viewing the screening video
satisfaction assessment questionnaire and understanding of the preoperative medical information for control group
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]
satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe
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]
State-Trait Anxiety Inventory (STAI-TRAIT) SCORE
Time frame: Baseline Day[ -90 / -7]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cesar Cartier, PI principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing access to the internet information platform in people with Thyroid, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cesar Cartier, PI (0467336895 ext. +33, c-cartier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE (time frame: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.