Anxiety Regional Anesthesia Pre-operativeStress RANCT04199442
Anxiety Assessment Before Regional Anesthesia.
An observational study of Anxiety Regional Anesthesia Pre-operative, run by University of Liege at 1 site in Belgium.
Trial summary
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Regional Anesthesia Pre-operative
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2019to 10 Nov 2020
- 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: Patients who come to the operating room for surgery under regional anesthesia.
Who may be able to join
- patient> 18 years
- surgery performed under general anesthesia or not but preceded by a regional anesthesia.
Who cannot join
- refusal of the patient
- psychiatric disorders (pathological anxiety, psychosis, depression)
- language barrier
- major drug impregnation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.
Read the detailed description
When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.
What is being measured
The primary outcome is the main question the study is designed to answer.
APAIS score
anxiety measurement score
Measured: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
STAI-6 score
anxiety measurement score
Measured: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start15 Dec 2019
- Primary completion2 Jan 2020
- Study completion10 Nov 2020
Why it stopped: Sanitary crisis du to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety Regional Anesthesia Pre-operativeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Goffin, University of Liege
- Investigators
- Pierre Goffin, Principal investigator, MontLegia Hospital, Groupe Santé CHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199442
- Sponsor's protocol ID
- 00011
- Acronym
- Stress RA
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
PubMed 30205837Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.
- ClinicalTrials.gov ID
- NCT04199442
- Acronym / sponsor ID
- Stress RA / 00011
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sanitary crisis du to Covid-19
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 16 Dec 2019 (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.
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.
Detailed description
When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who come to the operating room for surgery under regional anesthesia.
Key inclusion criteria (2 listed)
- patient> 18 years
- surgery performed under general anesthesia or not but preceded by a regional anesthesia.
Key exclusion criteria (4 listed)
- refusal of the patient
- psychiatric disorders (pathological anxiety, psychosis, depression)
- language barrier
- major drug impregnation.
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
APAIS score
Time frame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
anxiety measurement score
STAI-6 score
Time frame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
anxiety measurement score
Results and safety
The study was stopped early (reason given: Sanitary crisis du to Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 30205837Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
- Background: PubMed 1393159Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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.
Pierre Goffin principal investigator
MontLegia Hospital, Groupe Santé CHC
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 Anxiety Regional Anesthesia Pre-operative, run by University of Liege at 1 site in Belgium.
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 4 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: stopped early, as of the sponsor's last update on 12 Nov 2020. 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 Belgium. 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?
The study was stopped early (reason given: Sanitary crisis du to Covid-19). Results are not available in the source record.
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?
APAIS score (time frame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made). The study lists 2 primary outcomes in all. 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 NCT04199442, which also lists 2 linked publications.
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 12 Nov 2020.