NCT03261648

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

July 27, 2017

Last Update Submit

August 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Study the link between the patient's and his partner's anxiety

    day 1

  • Evaluate the link between the patient's anxiety and the patient's pain

    day 1

Study Arms (2)

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

Other: State-Trait-Anxiety Inventory (Forme Y) questionnaireOther: pain level scale

partner of the hospitalized patient

100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire

Other: State-Trait-Anxiety Inventory (Forme Y) questionnaire

Interventions

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

hospitalized patientpartner of the hospitalized patient

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

hospitalized patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people admited in the emergency department and his partner

You may qualify if:

  • 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
  • Patient and partner Francophone or with a good understanding of French

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Anxiety DisordersEmergencies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vincent BOUNES, MD

    University Hospital of Toulouse, Toulouse, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 25, 2017

Study Start

May 23, 2017

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations