MedDataX Logo

Anxiety of Patient and His Partner During Admission to Emergency Department

NCT ID: NCT03261648

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Emergencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

State-Trait-Anxiety Inventory (Forme Y) questionnaire

Intervention Type OTHER

after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.

pain level scale

Intervention Type OTHER

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

State-Trait-Anxiety Inventory (Forme Y) questionnaire

Intervention Type OTHER

after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

State-Trait-Anxiety Inventory (Forme Y) questionnaire

after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.

Intervention Type OTHER

pain level scale

as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vincent BOUNES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse, Toulouse, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00511-52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17-0033

Identifier Type: -

Identifier Source: org_study_id