Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Validation of the french version of the TEX-Q.
研究概览
简要总结
It is now known that the level of patients' expectations about a treatment (intervention, medication) can influence their prognosis. Positive expectations impact the effectiveness of the intervention, while negative expectations may lead to adverse events.
It would therefore be useful to measure these expectations. However, there is no standardized questionnaire to report the overall level of expectation in the pre-operative phase.
A team (led by Pr Meike C Shedden-Mora) has recently developed a questionnaire that aims to assess a patient's general level of expectation regarding a therapeutic intervention, taking into account the direct benefits and the expected adverse effects. This questionnaire, the brief version of the treatment expectation questionnaire (TEX-Q) is composed of 15 items.
There's currently no French translation of the TEX-Q, nor has it been tested on a population scheduled for surgery.
In addition to expectations regarding the surgical procedure, patients seem to have various expectations regarding the impact and specific role of anesthesia. Little literature exists on specific expectations regarding the role of anesthesia.
Thus, we believe it is necessary to validate a French version of the TEX-Q questionnaire (TEX-Q-F) applied to the context of scheduled surgery, as well as to evaluate the specific expectations of anesthesia.
详细描述
Patients' treatment expectations are an important predictor of the impact of a therapeutic intervention (medical or psychological).
They can induce subjective and psychological changes, constituting a central mechanism of placebo and nocebo effects. Positive expectations influence the effectiveness of the intervention, whereas negative expectations may lead to adverse events. This finding also appears to be true in surgery, with a level of preoperative expectation appearing to be associated with postoperative quality of life.
The large number of existing scales measuring treatment expectancy has been identified as an important limitation to the expansion of the use of these tools. Indeed, most of them are restricted to use for a specific condition or intervention, or even focus on only one facet of expectations (either positive or negative). This observation is even more true in the field of surgery, where a recent systematic review reports that there is currently no standardised questionnaire to report the level of expectation in the preoperative phase.
A team has recently developed a questionnaire that aims to assess, in a general way, the degree of expectation of a patient regarding a therapeutic intervention, taking into account the direct benefits and undesirable effects expected through an impact that would be positive or negative. This questionnaire is composed of 35 items rated from 0 to 10 and assessing several dimensions of expectations. It was developed in English and German.
Since then, this team has developed a shorter version of the questionnaire (15 items scored from 0 to 10) to facilitate its clinical use, for which the psychometric parameters have been validated (article submitted).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥ 18 years);
- •Admitted for scheduled surgery in the surgical areas of orthopaedics, visceral surgery (excluding colonoscopy), neurosurgery (excluding intracranial surgery), urological, gynaecological, maxillofacial and ear, nose and throat (ENT) surgery.
- •French speaking ;
- •Able to answer the questionnaires, alone or with the help of a third party;
- •Willing to participate in the study.
- •Not suffering from a psychiatric or neurological pathology compromising cooperation with the protocol,
- •Patients not already included in the study during a previous surgery,
- •Date of surgery scheduled more than 7 days after the date of the anesthesia consultation,
- •Non-pregnant women.
排除标准
- •Withdrawing of consent
结局指标
主要结局
Validation of the french version of the TEX-Q.
时间窗: At the anesthesia consultation (One month before surgery)
Evaluate the validity of the French version of the brief version of the TEX-Q to assess preoperative expectations before scheduled surgery
次要结局
- Assessment of the association between expectations and the quality of postoperative recovery.(At 24 hours after surgery)
- Minimal important difference(At the anesthesia consultation (One month before surgery))
- Assessment of the association between expectations and patient's satisfaction about the care provided.(At 24 hours after surgery)