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

ConditionThyroid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Difficulty understanding the French language

Lack of internet access

Persons placed under the protection of justice,

Person under guardianship or curatorship

Trial design

Design model

Parallel

Treatments tested in this trial

  • access to the internet information platform

    Other intervention

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: access to the internet information platformActive comparator 1 intervention
Group B: usual preoperative informationNo intervention 0 interventions

Trial outcomes

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

Other outcomes

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