ExpectationsTEX-Q-FNCT05254704
Validation of the French Version of the TEX-Q Questionnaire.
An observational study of Expectations and Anesthesia, run by University Hospital, Angers.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Expectations, Anesthesia, Surgery
- What is being tested?
- TEX-Q-F before scheduled surgery
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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,
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- 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.
Who cannot join
- Withdrawing of consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.
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.
Read more
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.
Read the 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.
- Conditions
- Expectations, Anesthesia, Surgery, Quality of Life, Patient Satisfaction, Anesthesia Awareness
- Being tested
- TEX-Q-F before scheduled surgery
- Keywords
- Scheduled surgery, Quality of Recovery
- Medical subject headings
- Patient Satisfaction, Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEX-Q-F before scheduled surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group - assessment of reproductibility of TEX-Q-F | This groupe will fill in the questionnaire twice :
* at first before the anesthesia consultation
* then, 7 days after the consultation (without further information) This group will be composed of 100 subjects.
We will then assess the influence of their answers on their recovery by collecting their answer of QoR-15 (quality of recovery) and EVAN-G (satisfaction) at 24 hours after the surgery. Receives: Other: TEX-Q-F before scheduled surgery | |
| Group - assessment of the responsiveness of the questionnaire after information | This group will also fill in the questionnaire twice :
* at first before the anesthesia consultation
* then, 7 days after the consultation and AFTER a phone interview (about 15 minutes) with an experienced practitioner to provide appropriate information concerning the anesthesia and the postoperative rehabilitation process.
This group will also be composed of 100 subjects.
We will then assess the influence of their answers on their recovery by collecting their answer of QoR-15 (quality of recovery) and EVAN-G (satisfaction) at 24 hours after the surgery. Receives: Other: TEX-Q-F before scheduled surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the anesthesia consultation (One month before surgery)
Secondary outcomes (3)
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)
Measured: At 24 hours after surgery
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
Measured: At 24 hours after surgery
Minimal important difference
Estimate minimal important difference from the TEX-Q-F questionnaire in the surgery population.
Measured: At the anesthesia consultation (One month before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExpectationsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254704
- Sponsor's protocol ID
- 2021-A03229-32
- Acronym
- TEX-Q-F
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32819942
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the TEX-Q Questionnaire to Assess Patient's Expectations Regarding Their Surgery and Their Anesthesia.
- ClinicalTrials.gov ID
- NCT05254704
- Acronym / sponsor ID
- TEX-Q-F / 2021-A03229-32
- Conditions
- Expectations, Anesthesia, Surgery, Quality of Life, Patient Satisfaction, Anesthesia Awareness
- Keywords
- Scheduled surgery, Quality of Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group - assessment of reproductibility of TEX-Q-F | – | Other: TEX-Q-F before scheduled surgeryThis groupe will fill in the questionnaire twice : * at first before the anesthesia consultation * then, 7 days after the consultation (without further information) This group will be composed of 100 subjects. We will then assess the influence of their answers on their recovery by collecting their answer of QoR-15 (quality of recovery) and EVAN-G (satisfaction) at 24 hours after the surgery. |
| Group - assessment of the responsiveness of the questionnaire after information | – | Other: TEX-Q-F before scheduled surgeryThis group will also fill in the questionnaire twice : * at first before the anesthesia consultation * then, 7 days after the consultation and AFTER a phone interview (about 15 minutes) with an experienced practitioner to provide appropriate information concerning the anesthesia and the postoperative rehabilitation process. This group will also be composed of 100 subjects. We will then assess the influence of their answers on their recovery by collecting their answer of QoR-15 (quality of recovery) and EVAN-G (satisfaction) at 24 hours after the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Withdrawing of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEX-Q-F before scheduled surgeryThe 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. | Other | Group - assessment of reproductibility of TEX-Q-F, Group - assessment of the responsiveness of the questionnaire after information |
Primary outcome
Validation of the french version of the TEX-Q.
Time frame: 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
3 secondary outcomes
Assessment of the association between expectations and the quality of postoperative recovery.
Time frame: At 24 hours after surgery
Assessment of the association between expectations and patient's satisfaction about the care provided.
Time frame: At 24 hours after surgery
Minimal important difference
Time frame: At the anesthesia consultation (One month before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Results publication: PubMed 32819942Alberts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Expectations and Anesthesia, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime LEGER, MD (02 41 35 36 37 ext. +33, Maxime.Leger@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the french version of the TEX-Q. (time frame: At the anesthesia consultation (One month before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.