AnxietyANXURGNCT03261648
Anxiety of Patient and His Partner During Admission to Emergency Department
An observational study of Anxiety and Emergencies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Emergencies
- What is being tested?
- State-Trait-Anxiety Inventory (Forme Y) questionnaire and pain level scale
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2017to 6 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people admited in the emergency department and his partner
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department
Read the 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).
- Conditions
- Anxiety, Emergencies
- Being tested
- State-Trait-Anxiety Inventory (Forme Y) questionnaire, pain level scale
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait-Anxiety Inventory (Forme Y) questionnaireOther
after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
pain level scaleOther
as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: State-Trait-Anxiety Inventory (Forme Y) questionnaire; Other: pain level scale | |
| partner of the hospitalized patient | 100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire Receives: Other: State-Trait-Anxiety Inventory (Forme Y) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (2)
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
Measured: day 1
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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start23 May 2017
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent BOUNES, MD, Principal investigator, University Hospital of Toulouse, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261648
- Sponsor's protocol ID
- RC31/17-0033
- Other IDs
- 2017-A00511-52
- Acronym
- ANXURG
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety of Patient and His Partner During Admission to Emergency Department
- ClinicalTrials.gov ID
- NCT03261648
- Acronym / sponsor ID
- ANXURG / RC31/17-0033
- Conditions
- Anxiety, Emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospitalized patient | – | Other: State-Trait-Anxiety Inventory (Forme Y) questionnaire, Other: pain level scale100 patients will completed the 'State-Trait-Anxiety Inventory (Forme Y) questionnaire Patients will evaluated here pain answering to a pain level scale |
| partner of the hospitalized patient | – | Other: State-Trait-Anxiety Inventory (Forme Y) questionnaire100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people admited in the emergency department and his partner
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| State-Trait-Anxiety Inventory (Forme Y) questionnaireafter admission in the emergency department, patient and his partner will completed STAI Y questionnaire. | Other | hospitalized patient, partner of the hospitalized patient |
| pain level scaleas usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten | Other | hospitalized patient |
Primary outcome
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
2 secondary outcomes
Study the link between the patient's and his partner's anxiety
Time frame: day 1
Evaluate the link between the patient's anxiety and the patient's pain
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent BOUNES, MD principal investigator
University Hospital of Toulouse, Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Emergencies, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the anxiety of the patient with that of his partner (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.