- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261648
Anxiety of Patient and His Partner During Admission to Emergency Department (ANXURG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Admission to an emergency department is a major source of anxiety for the patient. Anxiety plays not only a role in its emotional state but can also have consequences on the taking care of the patient and especially on the analgesic procedure.
Since pain is one of the first causes of emergency admission, patient anxiety should not be overlooked. In the emergency department, patient consults frequently, with his partner . Anxiety can also affect the partner, which may affect the patient. No studies have yet demonstrated this correlation.
This study will evaluate, the anxiety of both parties and show the presence or not of an influence of the partner's anxiety on the patient using a standardized questionnaire, the State-Trait Anxiety Inventory- form Y (STAI-Y).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31000
- University Hospital of Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Admission to emergency department accompanied by his partner (lives in concubinage with the patient)
- Nurse patient's classification score up or equal to 3, 4 or 5
- Oral consent given to the inclusion by the patient and the partner
- Patient and partner Francophone or with a good understanding of French
Exclusion Criteria:
- Patient under a system of legal protection
- Non-Communicating Patient and partner
- Patient and partner unable to write
- Refusal of patient or partner
- Admission of the patient with shock treatment corresponding to the nurse patient's classification score 1 and 2
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
hospitalized patient
100 patients will completed the 'State-Trait-Anxiety Inventory (Forme Y) questionnaire Patients will evaluated here pain answering to a pain level scale
|
after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten
|
|
partner of the hospitalized patient
100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire
|
after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the anxiety of the patient with that of his partner
Time Frame: day 1
|
The anxiety will be evaluated by the State-Trait-Anxiety Inventory (Forme Y) questionnaire
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study the link between the patient's and his partner's anxiety
Time Frame: day 1
|
A corelation will be do between the score obtained by the patient and the score obtained by the partner at the STAI-Y questionnaire
|
day 1
|
|
Evaluate the link between the patient's anxiety and the patient's pain
Time Frame: day 1
|
The patient's pain will be evaluated orally asking to him to use a scale pain to 0 of 10
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent BOUNES, MD, University Hospital of Toulouse, Toulouse, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/17-0033
- 2017-A00511-52 (Other Identifier: ID-RCB)
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.
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