AnxietyNCT03605420
Relatives Visit Prior to Hospital Admission & Intensive Care Unit
A study testing Family visit prior to hospital admission in people with Anxiety and Depression, run by Universidad de León at 1 site in Spain.
Trial summary
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Care Unit Syndrome
- What is being tested?
- Family visit prior to hospital admission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 22 Aug 2018to 25 Jan 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family of a patient for hospital admission for surgery
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.
- Conditions
- Anxiety, Depression, Care Unit Syndrome
- Being tested
- Family visit prior to hospital admission
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family visit prior to hospital admissionOther
Family receiving one visit prior to hospital admission for surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Receiving one family visit prior to hospital admission Receives: Other: Family visit prior to hospital admission |
| Control group | No intervention | Without receiving one family visit prior to hospital admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hospital Anxiety and Depression Scale
Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).
Measured: Change from Baseline anxiety and depression at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start22 Aug 2018
- Primary completion20 Jan 2019
- Study completion25 Jan 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605420
- Sponsor's protocol ID
- ICU-visit-relatives
- Status last verified
- Jan 2019
- First submitted
- 21 Jul 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03605420
- Acronym / sponsor ID
- ICU-visit-relatives
- Conditions
- Anxiety, Depression, Care Unit Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 30 Jul 2018 (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.
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Family visit prior to hospital admissionReceiving one family visit prior to hospital admission |
| Control group | No intervention | –Without receiving one family visit prior to hospital admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family of a patient for hospital admission for surgery
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| Family visit prior to hospital admissionFamily receiving one visit prior to hospital admission for surgery | Other | Experimental group |
Primary outcome
The Hospital Anxiety and Depression Scale
Time frame: Change from Baseline anxiety and depression at 90 days
Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).
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 28 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family visit prior to hospital admission in people with Anxiety and Depression, run by Universidad de León at 1 site in Spain.
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 1 inclusion and 1 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 28 Jan 2019. 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 Spain. 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?
The Hospital Anxiety and Depression Scale (time frame: Change from Baseline anxiety and depression at 90 days). 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 28 Jan 2019.