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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03261648
Other study ID # RC31/17-0033
Secondary ID 2017-A00511-52
Status Completed
Phase N/A
First received July 27, 2017
Last updated August 30, 2017
Start date May 23, 2017
Est. completion date July 6, 2017

Study information

Verified date August 2017
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department


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).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 6, 2017
Est. primary completion date July 6, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
State-Trait-Anxiety Inventory (Forme Y) questionnaire
after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
pain level scale
as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten

Locations

Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the anxiety of the patient with that of his partner The anxiety will be evaluated by the State-Trait-Anxiety Inventory (Forme Y) questionnaire day 1
Secondary Study the link between the patient's and his partner's anxiety 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
Secondary Evaluate the link between the patient's anxiety and the patient's pain The patient's pain will be evaluated orally asking to him to use a scale pain to 0 of 10 day 1
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