Assessment of Fears of Patients Standing at the Operating Block

Sponsor
Ch Mont de Marsan (Other)
Overall Status
Completed
CT.gov ID
NCT04299555
Collaborator
(none)
300
1
3.9
76.7

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Fears of Patients Standing at the Operating Block
    Actual Study Start Date :
    Sep 1, 2018
    Actual Primary Completion Date :
    Dec 29, 2018
    Actual Study Completion Date :
    Dec 29, 2018

    Outcome Measures

    Primary Outcome Measures

    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) [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.

    Secondary Outcome Measures

    1. determine the factors associated to these fears (Before and after anesthesia) [before anesthesia and after anesthesia, an average of 1 day]

      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.

    2. determine the anxiety (Before and after anesthesia) [before anesthesia and after anesthesia, an average of 1 day]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • refused patient

    • Patients with reduced mobility preoperatively

    • patient under tutorship or curatorship

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 centre hospitalier Dax Dax France 40100

    Sponsors and Collaborators

    • Ch Mont de Marsan

    Investigators

    • Principal Investigator: Karam SAMII, MD, CH de Mont de Marsan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ch Mont de Marsan
    ClinicalTrials.gov Identifier:
    NCT04299555
    Other Study ID Numbers:
    • 2018-Ao1820-55
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 6, 2020