Cognition of OsteopathNCT06695806
Measurement of the Intolerance to Uncertainty in Osteopaths
An observational study of Cognition of Osteopath, run by Institut des Hautes Etudes Osteopathiques de Nantes at 1 site in France.
Trial summary
Clinical reasoning is a challenging, complex, multi-dimensional, essentially introspective and poorly understood cognitive process, as well as a crucial skill for osteopaths and health professionals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cognition of Osteopath
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Students are selected in three different fench schools of osteopathy, and osteopaths are selected from among former graduates of these schools.
Who may be able to join
- Student in osteopathy (3rd, 4th or 5th year) or have a diploma in osteopathy
- Provide an informed consent
Who cannot join
- Patients refusing to take part in the study.
- Pregnant women
- Patients under legal protection
- Patients who are protected adults or adults unable to express their consent.
- Withdrawal of consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Measurement and Evolution of the Intolerance to Uncertainty in Osteopaths and Osteopathic Students: a Longitudinal Study
Clinical reasoning is a challenging, complex, multi-dimensional, essentially introspective and poorly understood cognitive process, as well as a crucial skill for osteopaths and health professionals. It can be agreed that this includes diagnosing the patient's condition, making therapeutic decisions to improve that condition, and the practitioner's ability to assess the patient's prognosis. Individual clinical expertise is acquired through experience. Each healthcare professional develops their own approach to problem-solving and decision-making, influenced by factors such as personality, preferences, clinical perception, and professional practices. It is important to be aware that certain factors can influence their judgement and potentially affect the quality of their work. It is possible that certain factors may influence their judgement and potentially lead to errors in their decision-making, as they can be influenced by cognitive biases such as intolerance of uncertainty. Uncertainty intolerance is defined as a personal disposition characterised by negative beliefs about uncertainty and its consequences, coupled with an underlying apprehension about the unknown. Uncertainty affects the behaviour of individuals by creating a need for certainty, which in turn affects the clinical reasoning and decision-making of healthcare professionals.
The objective of this study is to assess the level of intolerance to uncertainty among osteopathic students and osteopaths using an online self-report questionnaire. A second questionnaire will be sent out six months after the first, allowing to assess individual changes in this intolerance over time. Furthermore, the impact of being a graduate, anxiety and the type of osteopath responding to the questionnaire will be examined. The final measure will be evaluated using a classification method called latent class analysis. This will be based on responses to questions about their relationship to evidence-based practice, dogmatism and their thoughts about the impact of osteopathic treatment.
The aim of this study is to carry out a psychometric validation of the intolerance to uncertainty questionnaire on a population of osteopaths.
- Conditions
- Cognition of Osteopath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| osteopath | Participants should be osteopaths or students in osteopathy. They need to understand french and give their consent before answering questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance to uncertainty
Total score of the questionnaire: Intolerance of Uncertainty Scale in Health (IUS-12-H), consisting of 12 questions. Participants answer on a Likert scale ranging from "not at all characteristic of me" (1), "somewhat characteristic of me" (2), "somewhat characteristic of me" (3), "very characteristic of me" (4), and "very characteristic of me" (5). The score ranges from 12 (no intolerance of uncertainty) to 60 (great intolerance of uncertainty).
Measured: at enrollement
Secondary outcomes (1)
Change in Intolerance to uncertainty
Measured: From enrollement to the second assessment, six mounth later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start15 Oct 2024
- Primary completion15 Oct 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition of OsteopathStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de Nantes
- Sponsor type
- University, hospital or other
- Collaborators
- ad hoc lab, CEESO paris, IOR B
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695806
- Sponsor's protocol ID
- MICO
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Evolution of the Intolerance to Uncertainty in Osteopaths and Osteopathic Students: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT06695806
- Acronym / sponsor ID
- MICO
- Conditions
- Cognition of Osteopath
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de NantesUniversity, hospital or other
- Collaborators
- ad hoc lab, CEESO paris, IOR B
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Nov 2024 (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.
Clinical reasoning is a challenging, complex, multi-dimensional, essentially introspective and poorly understood cognitive process, as well as a crucial skill for osteopaths and health professionals. It can be agreed that this includes diagnosing the patient's condition, making therapeutic decisions to improve that condition, and the practitioner's ability to assess the patient's prognosis. Individual clinical expertise is acquired through experience. Each healthcare professional develops their own approach to problem-solving and decision-making, influenced by factors such as personality, preferences, clinical perception, and professional practices. It is important to be aware that certain factors can influence their judgement and potentially affect the quality of their work. It is possible that certain factors may influence their judgement and potentially lead to errors in their decision-making, as they can be influenced by cognitive biases such as intolerance of uncertainty. Uncertainty intolerance is defined as a personal disposition characterised by negative beliefs about uncertainty and its consequences, coupled with an underlying apprehension about the unknown. Uncertainty affects the behaviour of individuals by creating a need for certainty, which in turn affects the clinical reasoning and decision-making of healthcare professionals.
The objective of this study is to assess the level of intolerance to uncertainty among osteopathic students and osteopaths using an online self-report questionnaire. A second questionnaire will be sent out six months after the first, allowing to assess individual changes in this intolerance over time. Furthermore, the impact of being a graduate, anxiety and the type of osteopath responding to the questionnaire will be examined. The final measure will be evaluated using a classification method called latent class analysis. This will be based on responses to questions about their relationship to evidence-based practice, dogmatism and their thoughts about the impact of osteopathic treatment.
The aim of this study is to carry out a psychometric validation of the intolerance to uncertainty questionnaire on a population of osteopaths.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteopath | – | –Participants should be osteopaths or students in osteopathy. They need to understand french and give their consent before answering questionnaire. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Students are selected in three different fench schools of osteopathy, and osteopaths are selected from among former graduates of these schools.
Key inclusion criteria (2 listed)
- Student in osteopathy (3rd, 4th or 5th year) or have a diploma in osteopathy
- Provide an informed consent
Key exclusion criteria (5 listed)
- Patients refusing to take part in the study.
- Pregnant women
- Patients under legal protection
- Patients who are protected adults or adults unable to express their consent.
- Withdrawal of consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intolerance to uncertainty
Time frame: at enrollement
Total score of the questionnaire: Intolerance of Uncertainty Scale in Health (IUS-12-H), consisting of 12 questions. Participants answer on a Likert scale ranging from "not at all characteristic of me" (1), "somewhat characteristic of me" (2), "somewhat characteristic of me" (3), "very characteristic of me" (4), and "very characteristic of me" (5). The score ranges from 12 (no intolerance of uncertainty) to 60 (great intolerance of uncertainty).
1 secondary outcome
Change in Intolerance to uncertainty
Time frame: From enrollement to the second assessment, six mounth later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition of Osteopath, run by Institut des Hautes Etudes Osteopathiques de Nantes at 1 site in France.
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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance to uncertainty (time frame: at enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.