NCT Number: NCT04571736
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Montpellier, Hérault, 34295, France
Location status: Recruiting
Agnes Viquesnel, sub-PI
SUB_INVESTIGATOR
Cesar Cartier, PI
PRINCIPAL_INVESTIGATOR
Susana LEONARD, CRA
CONTACT
04 67 33 61 56 ext. +33
Thibault Kennel, sub- PI
SUB_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
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]
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: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
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: post-operative visit Day [5-30] after viewing the screening video
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: Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
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: 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]
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: Baseline Day[ -90 / -7]
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
Acronym: AMEDOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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