Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 6:36 PM
Study NCT ID:
NCT05254704
Status:
UNKNOWN
Last Update Posted:
2022-02-24
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Version of the TEX-Q Questionnaire.
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEX-Q-F
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: