Assessment of Fears of Patients Standing at the Operating Block

NCT04299555 | Completed

• 1 other identifier: 2018-Ao1820-55
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety and Fear

Outcome Measures

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.

  before anesthesia and after anesthesia, an average of 1 day

Secondary Outcomes (2)

• determine the factors associated to these fears (Before and after anesthesia)

  before anesthesia and after anesthesia, an average of 1 day

• determine the anxiety (Before and after anesthesia)

  before anesthesia and after anesthesia, an average of 1 day

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ch Mont de Marsan: lead

Study Sites (1)

centre hospitalier Dax

Dax, 40100, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Karam SAMII, MD

  CH de Mont de Marsan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: March 6, 2020
• Study Start: September 1, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

FR (1)