- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03355404
Impact of the "Standing Patient" Pathway on Preoperative Anxiety. (ANXIPADE)
Evaluate the Impact of the "Standing Patient" Pathway on Preoperative Anxiety.
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caen, France
- Caen University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "Standing Patient"
|
patient goes standing to the surgery room
|
No Intervention: "Standardized management in stretcher"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
APAIS score to the operating room installation
Time Frame: baseline
|
APAIS scale
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-A01253-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
-
EgymedicalpediaCompletedSurgery | Pediatric SurgeryEgypt
Clinical Trials on standing patient
-
Science and Research Centre KoperUniversity of MichiganRecruitingPain, Acute | Work-Related Condition | Muscle Tone Abnormalities | Sensory DeficitSlovenia
-
University of MinnesotaMayo ClinicCompleted
-
University of New BrunswickHorizon Health Network; St. Thomas University; Universite de Moncton; Canadian...CompletedFrailty | Physical Disability | Sedentary BehaviorCanada
-
Maastricht UniversityCompletedProblem-Based LearningNetherlands
-
Science and Research Centre KoperUniversity of MichiganUnknownCognitive Change | Aging | Diabete MellitusUnited States
-
Toronto Rehabilitation InstituteOntario Neurotrauma FoundationCompletedSpinal Cord Injury. | Osteoporosis.Canada
-
University of ChicagoActive, not recruitingRespiratory FailureUnited States
-
Boston Medical CenterWithdrawnParental/Patient SatisfactionUnited States
-
IRCCS Policlinico S. DonatoRecruitingHealthy | Cerebral Autoregulation | Autonomic Nervous SystemItaly
-
Milton S. Hershey Medical CenterDysautonomia InternationalCompletedPostural Tachycardia Syndrome | Ehlers-Danlos SyndromeUnited States