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Impact of the "Standing Patient" Pathway on Preoperative Anxiety. (ANXIPADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355404
Recruitment Status : Unknown
Verified November 2017 by University Hospital, Caen.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to bring about a global care of the patient by establishing a safe and quality climate. With this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "Fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room.

The ambulatory surgery department of the CHU of Caen welcomes and supports adults and children over 8 years old. The following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since December 2015. It seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and not dependent, he is accompanied and not taken away. The preservation of autonomy improves their feelings, especially in terms of dignity. It also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up.

However, studies reporting the benefit of this technique have rather evaluated the feelings of patients. To the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with appropriate tools seems essential to determine a real impact.

We hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. We have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. We propose to carry out a randomized study comparing the anxiety score using the APAIS scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater.

The duration of this study is evaluated at 2 years.


Condition or disease Intervention/treatment Phase
Surgery Other: standing patient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate the Impact of the "Standing Patient" Pathway on Preoperative Anxiety.
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: "Standing Patient" Other: standing patient
patient goes standing to the surgery room

No Intervention: "Standardized management in stretcher"



Primary Outcome Measures :
  1. APAIS score to the operating room installation [ Time Frame: baseline ]
    APAIS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient.
  • Patient hospitalized for surgery.
  • Patient supported in the south block.
  • Patients agreeing to participate in the study.
  • Patient speaking and understanding French.

Exclusion Criteria:

  • Patient with reduced mobility.
  • Patient with a mental disability.
  • Patient suffering from a severe psychiatric pathology.
  • Major patient protected.
  • Patient does not speak or understand French.
  • Refusal of the patient to participate in the study.
  • Patient who has been premedicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355404


Locations
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France
Caen University Hospital
Caen, France
Contact: nathalie LEMONNIER    0231272038    lemonnier-n@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03355404    
Other Study ID Numbers: 2017-A01253-50
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No