Assessment of Fears of Patients Standing at the Operating Block

Anxiety and Fear Clinical Trial

Official title:

Assessment of Fears of Patients Standing at the Operating Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299555
• Other study ID #: 2018-Ao1820-55
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: December 29, 2018

Study information

• Verified date: June 2023
• Source: Ch Mont de Marsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear

Locations

Country	Name	City	State
France	centre hospitalier Dax	Dax

Sponsors (1)

Lead Sponsor	Collaborator
Ch Mont de Marsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before anesthesia and after anesthesia, an average of 1 day
Secondary	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.	before anesthesia and after anesthesia, an average of 1 day
Secondary	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.	before anesthesia and after anesthesia, an average of 1 day