Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
usual preoperative information
medical information delivered to the patient before any surgery
access to the internet information platform
usual preoperative information and access to the internet information platform
干预措施: access to the internet information platform (Other)
结局指标
主要结局
Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
时间窗: 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.
次要结局
- satisfaction assessment questionnaire and understanding of the preoperative medical information for control group(Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30])
- specific questionnaire EDOP(post-operative visit Day [5-30] after viewing the screening video)
- State-Trait Anxiety Inventory (STAI-ETAT) SCORE(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(Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30])
- State-Trait Anxiety Inventory (STAI-TRAIT) SCORE(Baseline Day[ -90 / -7])
- satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe(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])