Validation of the French Version of the TEX-Q Questionnaire.

Quality of Life Clinical Trial

— TEX-Q-F  

Official title:

Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05254704
• Other study ID #: 2021-A03229-32
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Angers
• Contact: Maxime LEGER, MD
• Phone: 02 41 35 36 37
• Email: Maxime.Leger[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia Awareness
• Expectations
• Intraoperative Awareness
• Patient Satisfaction
• Quality of Life
• Surgery

Intervention

Other:
• TEX-Q-F before scheduled surgery
The TEX-Q-F questionnaire (French version of the breif version of the TEX-Q) contains 15 questions to assess the patient's overall expectations concerning the surgery. The first 11 questions concern the patient's expectations regarding the postoperative period: pain and functional recovery. The last 4 questions focus on the patient's hopes for the outcome of the surgery. Each item is scored from 0 to 10, according to the intensity of the level of expectation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

References & Publications (1)

Alberts J, Löwe 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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the french version of the TEX-Q.	Evaluate the validity of the French version of the brief version of the TEX-Q to assess preoperative expectations before scheduled surgery	At the anesthesia consultation (One month before surgery)
Secondary	Assessment of the association between expectations and the quality of postoperative recovery.	Evaluation by answering French version of quality of recovery score (QoR-15), ranged between 0 (lowest value) and 150 (highest value)	At 24 hours after surgery
Secondary	Assessment of the association between expectations and patient's satisfaction about the care provided.	Evaluation by answering EVAN-G questionnaire, composed of 26 items and 6 dimensions. . Each dimension was named according to its constitutive items: attention (5 items), privacy (4 items), information (5 items), pain (5 items), discomfort (5 items), and waiting (2 items). Items were answered using a five-point Likert scale, where 1 was much less than expected, 2 was less than expected, 3 was expected, 4 was more than expected, and 5 was much more than expected. The scores for negatively worded items were reversed so that higher scores indicated a higher level of satisfaction. the score of each dimension was obtained by computing the mean of the item scores of the dimension. All dimension scores were linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 indicating the worst. The global satisfaction score was computed as the mean of the dimension scores	At 24 hours after surgery
Secondary	Minimal important difference	Estimate minimal important difference from the TEX-Q-F questionnaire in the surgery population.	At the anesthesia consultation (One month before surgery)