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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02241-56 | Other Identifier | IDRCB |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| access to the internet information platform | Active Comparator | usual preoperative information and access to the internet information platform |
|
| usual preoperative information | No Intervention | medical information delivered to the patient before any surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| access to the internet information platform | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline Day [-90 / -7] and Surgery Day [-1 / 0] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesar Cartier, PI | Contact | 0467336895 | +33 | c-cartier@chu-montpellier.fr |
| Susana Leornard, CRA | Contact | 04 67 33 61 56 | +33 | s-leonard@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cesar Cartier, PI | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Gui de Chauliac | Recruiting | Montpellier | HĂ©rault | 34295 | France |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| 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). | 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). | 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. | 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. | 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. | 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. | Baseline Day[ -90 / -7] |