Validation of the French Version of the TEX-Q Questionnaire.
TEX-Q-F
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Apr 2022
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 24, 2022
February 1, 2022
3 months
February 14, 2022
February 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Assessment of the association between expectations and the quality of postoperative recovery.
At 24 hours after surgery
Assessment of the association between expectations and patient's satisfaction about the care provided.
At 24 hours after surgery
Minimal important difference
At the anesthesia consultation (One month before surgery)
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Withdrawing of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32819942RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2022
First Posted
February 24, 2022
Study Start
April 1, 2022
Primary Completion
July 1, 2022
Study Completion
August 1, 2022
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share