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CompletedNCT04299555Updated Jul 3, 2023

Assessment of Fears of Patients Standing at the Operating Block

An observational study in Anxiety and Fear, sponsored by Ch Mont de Marsan. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Ch Mont de Marsan · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 99 Years
Sex
All
01

Study 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. 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

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.

02

Conditions studied

  • Anxiety and Fear
03

In context

Lead sponsor

Ch Mont de Marsan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

any patient presenting at the block and corresponding to the criteria over a period of 3 months

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • refused patient
  • Patients with reduced mobility preoperatively
  • patient under tutorship or curatorship
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before anesthesia and after anesthesia, an average of 1 day

Secondary outcomes

  1. 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.

    Time frame: before anesthesia and after anesthesia, an average of 1 day

  2. 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.

    Time frame: before anesthesia and after anesthesia, an average of 1 day

07

Study locations

1 site
  • centre hospitalier Dax
    Dax, 40100, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04299555
Lead sponsor
Ch Mont de Marsan
Responsible party
Sponsor
First posted
Mar 6, 2020
Start date
Sep 1, 2018
Primary completion
Dec 29, 2018
Completion
Dec 29, 2018
Last update
Jul 3, 2023

Study contacts

Karam SAMII, MD
principal investigator · CH de Mont de Marsan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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