Clinical trial NCT05254704: Validation of the French Version of the TEX-Q Questionnaire.
Official title: Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Expectations
Anesthesia
Surgery
Quality of Life
Patient Satisfaction
Anesthesia Awareness
Keywords: Scheduled surgery
Quality of Recovery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for a surgery in the University Hospital of Angers, excepted intracranial surgery, cardiac surgery, or surgery wfor which the evaluation at 24 hours after surgery could be complicated.

Brief summary: 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.

Detailed description: 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).

So far, no French translation of this general assessment scale has been validated, nor has it been tested on a population scheduled for surgery. Similarly, until now, no evaluation of the association between the degree of preoperative expectations and the quality of post-operative recovery has been studied.

Furthermore, beyond expectations regarding the surgical procedure, patients seem to have expectations regarding the impact and the specific role of anesthesia. These expectations seem to be various and sometimes complex (not to feel nausea or pain, stay awake as much as possible, be sedated not to retain any memory of their procedure, and so on...). For example, although a Swedish team has shown that the experience of post-operative pain is correlated with the level of preoperative expectation, there is little literature on specific expectations regarding anesthesia.

Thus, it seems necessary to validate a French version of the simplified TEX-Q questionnaire (TEX-Q-F) applied to the context of scheduled surgery, as well as to evaluate the specific expectations of anesthesia.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Withdrawing of consent

Primary outcomes:
measure: Validation of the french version of the TEX-Q.
timeFrame: At the anesthesia consultation (One month before surgery)
Secondary outcomes:
measure: Assessment of the association between expectations and the quality of postoperative recovery.
timeFrame: At 24 hours after surgery
measure: Assessment of the association between expectations and patient's satisfaction about the care provided.
timeFrame: At 24 hours after surgery
measure: Minimal important difference
timeFrame: At the anesthesia consultation (One month before surgery)
Other outcomes:
Locations:
Study officials:
References:
citation: Alberts J, Lowe B, Glahn MA, Petrie K, Laferton J, Nestoriuc Y, Shedden-Mora M. Development of the generic, multidimensional Treatment Expectation Questionnaire (TEX-Q) through systematic literature review, expert surveys and qualitative interviews. BMJ Open. 2020 Aug 20;10(8):e036169. doi: 10.1136/bmjopen-2019-036169.