Anxiety and FearNCT04299555
Assessment of Fears of Patients Standing at the Operating Block
An observational study of Anxiety and Fear, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 1 site in France.
Trial summary
The term "outpatient" refers to all the medical, organizational and administrative care that allows the patient to leave the same day the structure where the ambulatory procedure was performed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anxiety and Fear
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 29 Dec 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient presenting at the block and corresponding to the criteria over a period of 3 months
Who may be able to join
- To be adult (18 years minimum)
- Have a good understanding of the French language
- A diagnosis requiring an endoscopic act.
- Being eligible for outpatient care during anesthesia consultation (ASA I-II and ASA III balanced, good preoperative mobility, understanding pre and postoperative instructions, ability to observe treatments, acceptable housing and hygiene conditions , access to a telephone, journey <1h for the first night).
- Have never been brought before to the operating room or standing endoscopy
- collection of the patient's non-opposition.
Who cannot join
- refused patient
- Patients with reduced mobility preoperatively
- patient under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
The term "outpatient" refers to all the medical, organizational and administrative care that allows the patient to leave the same day the structure where the ambulatory procedure was performed. The usual rule for patients undergoing endoscopic surgery or surgery under general anesthesia is to transport them to the endoscopy or operating room lying on a stretcher, even if they can walk independently.
In recent years, the procedure of bringing the patient standing in the operating room seems to have many advantages. It is readily accepted by patients and may even lessen their anxiety.
Read more
Nevertheless, reluctance and fears are sometimes expressed by patients who do not know this new procedure. Our team has introduced this procedure for patients admitted to the ambulatory hospitalization sector and to join the endoscopy sector.
The aim of our work is therefore to objectify the fears expressed by patients who have to go to the endoscopy room before general anesthesia and to evaluate their progress after endoscopy
Read the detailed description
Nowadays, the procedure of the patient standing in the operating room or in endoscopy has become frequent in the outpatient management of patients. Indeed the advantages are numerous: better fluidity of the patient circuits to the block, reduction of the stress of the operated one etc. Yet some patients might experience fears.
Thus, in order to improve our practice, we want to take into account your experience with this innovative procedure.
To determine patients' fears concerning their endoscopic standing before general anesthesia and to evaluate their evolution after this first experience
After your installation in the preoperative area, we submit a questionnaire that corresponds to the first part of the document and then accompanied by a hospital agent you will walk towards the entrance to the endoscopy room. These questions are about your possible fears and your degree of anxiety.
After an endoscopy under general anesthesia, you will be taken back to your stretcher room where you will complete the second part of the questionnaire which deals with the same topics as the questions asked before the endoscopy.
- Conditions
- Anxiety and Fear
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
determine and assess the fears of the patients who have never been transported to the OR by walking and to reassess their fears after their first experience (Before and after anesthesia)
determine the fears expressed by patients who have to go to the endoscopy room before general anesthesia and to evaluate their change after endoscopy with a simple numerical rating scale from 0 to 10 for 5 items. This numerical rating scale is completed by patient at two timepoint: before and after anesthesia. Value 0 corresponding to any fear to value 10 corresponding to maximal fear.
Measured: before anesthesia and after anesthesia, an average of 1 day
Secondary outcomes (2)
determine the factors associated to these fears (Before and after anesthesia)
determine the factors associated to these fears of the patients who have to go to the endoscopy room before general anesthesia and to evaluate their change after endoscopy with a simple numerical rating scale from 0 to 10. This numerical rating scale is completed by patient at two timepoint: before and after anesthesia. Value 0 corresponding to any fear to value 10 corresponding to maximal fear.
Measured: before anesthesia and after anesthesia, an average of 1 day
determine the anxiety (Before and after anesthesia)
evaluate their change of anxiety item before and after endoscopy with a simple numerical rating scale from 0 to 10. This numerical rating scale is completed by patient at two timepoint: before and after anesthesia. Value 0 corresponding to any anxiety to value 10 corresponding to very strong anxiety.
Measured: before anesthesia and after anesthesia, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Sep 2018
- Primary completion29 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karam SAMII, MD, Principal investigator, CH de Mont de Marsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299555
- Sponsor's protocol ID
- 2018-Ao1820-55
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fears of Patients Standing at the Operating Block
- ClinicalTrials.gov ID
- NCT04299555
- Acronym / sponsor ID
- 2018-Ao1820-55
- Conditions
- Anxiety and Fear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCESUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 6 Mar 2020 (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.
The term "outpatient" refers to all the medical, organizational and administrative care that allows the patient to leave the same day the structure where the ambulatory procedure was performed. The usual rule for patients undergoing endoscopic surgery or surgery under general anesthesia is to transport them to the endoscopy or operating room lying on a stretcher, even if they can walk independently.
In recent years, the procedure of bringing the patient standing in the operating room seems to have many advantages. It is readily accepted by patients and may even lessen their anxiety.
Nevertheless, reluctance and fears are sometimes expressed by patients who do not know this new procedure. Our team has introduced this procedure for patients admitted to the ambulatory hospitalization sector and to join the endoscopy sector.
The aim of our work is therefore to objectify the fears expressed by patients who have to go to the endoscopy room before general anesthesia and to evaluate their progress after endoscopy
Detailed description
Nowadays, the procedure of the patient standing in the operating room or in endoscopy has become frequent in the outpatient management of patients. Indeed the advantages are numerous: better fluidity of the patient circuits to the block, reduction of the stress of the operated one etc. Yet some patients might experience fears.
Thus, in order to improve our practice, we want to take into account your experience with this innovative procedure.
To determine patients' fears concerning their endoscopic standing before general anesthesia and to evaluate their evolution after this first experience
After your installation in the preoperative area, we submit a questionnaire that corresponds to the first part of the document and then accompanied by a hospital agent you will walk towards the entrance to the endoscopy room. These questions are about your possible fears and your degree of anxiety.
After an endoscopy under general anesthesia, you will be taken back to your stretcher room where you will complete the second part of the questionnaire which deals with the same topics as the questions asked before the endoscopy.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient presenting at the block and corresponding to the criteria over a period of 3 months
Key inclusion criteria (6 listed)
- To be adult (18 years minimum)
- Have a good understanding of the French language
- A diagnosis requiring an endoscopic act.
- Being eligible for outpatient care during anesthesia consultation (ASA I-II and ASA III balanced, good preoperative mobility, understanding pre and postoperative instructions, ability to observe treatments, acceptable housing and hygiene conditions , access to a telephone, journey <1h for the first night).
- Have never been brought before to the operating room or standing endoscopy
Key exclusion criteria (3 listed)
- refused patient
- Patients with reduced mobility preoperatively
- patient under tutorship or curatorship
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
determine and assess the fears of the patients who have never been transported to the OR by walking and to reassess their fears after their first experience (Before and after anesthesia)
Time frame: before anesthesia and after anesthesia, an average of 1 day
determine the fears expressed by patients who have to go to the endoscopy room before general anesthesia and to evaluate their change after endoscopy with a simple numerical rating scale from 0 to 10 for 5 items. This numerical rating scale is completed by patient at two timepoint: before and after anesthesia. Value 0 corresponding to any fear to value 10 corresponding to maximal fear.
2 secondary outcomes
determine the factors associated to these fears (Before and after anesthesia)
Time frame: before anesthesia and after anesthesia, an average of 1 day
determine the anxiety (Before and after anesthesia)
Time frame: before anesthesia and after anesthesia, an average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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.
Karam SAMII, MD principal investigator
CH de Mont de Marsan
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 and Fear, run by CHI MONT DE MARSAN ET PAYS DES SOURCES 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
determine and assess the fears of the patients who have never been transported to the OR by walking and to reassess their fears after their first experience (Before and after anesthesia) (time frame: before anesthesia and after anesthesia, an average of 1 day). 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 3 Jul 2023.