AnxietyEPECA30-2018NCT03977376
Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
A study testing Guide of hosting in people with Anxiety and Nurse-Patient Relations, run by University of Alcala at 1 site in Spain.
Trial summary
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Nurse-Patient Relations, Behavior
- What is being tested?
- Guide of hosting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2019to 26 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age limits: 18 years old.
- with hospital admission scheduled at 5ªA hospitalization service of the University Hospital of Guadalajara for surgical intervention with urological diagnosis
Who cannot join
- patients with cognitive deficit.
- patients with recurrent insomnia problems
- without Spanish language proficiency
- patients that have participated in a clinical trial in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention.
Read the detailed description
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing communication instrument: a Guide of Hosting for urological scheduled patients for surgical intervention.
The purpose of the proposed project is to establish the feasibility and acceptability of this guide to decrease the anxiety in this patients, using a randomized clinical trial like a research design, which would test the effectiveness of this communication instrument in comparation to a control condition (patients without guide of housting).
To achieve the investigators specific aims, the investigator conducted a randomized clinical trial (n=50), with two groups: intervention group (with Guide of Hosting) and control group (which shows a control condition).
Valuation instruments were two validated scales: ESAS y HADS. Anxiety was the primary outcome variable assessed in the RCT; depression and pain were a secondary outcomes variables.
- Conditions
- Anxiety, Nurse-Patient Relations, Behavior
- Being tested
- Guide of hosting
- Keywords
- anxiety, Urogical, Guide of Hosting, Comunication instrument, Patients
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guide of hostingOther
Guide of hosting with information about hospitalization to decrease anxiety
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting. Receives: Other: Guide of hosting |
| Control | No intervention | Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety: Hospital Anxiety and Depression Scale (HADS)
To assess anxiety and depressive symptoms in a general medical population. There are 7 depression items measuring cognitive and emotional aspects of depression, predominantly anhedonia, intermingled with 7 anxiety items that focus on cognitive and emotional aspects of anxiety. Somatic items relating to emotional and physical disorders are excluded.
With 14 items.
Measured: 4-5 months
Anxiety: Edmonton Symptom Assessment System (ESAS)
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospilatation, with ratings ranging from 0 (none, best) to 10 (worst).
Measured: 4-5 months
Secondary outcomes (1)
Pain: Edmonton Symptom Assessment System (ESAS)
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start3 Jan 2019
- Primary completion30 Apr 2019
- Study completion26 May 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Gracia Ruiz García, University of Alcala
- Investigators
- Carmen Gracia Ruiz Garcia, Principal investigator, Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977376
- Sponsor's protocol ID
- EPECA30-2018
- Acronym
- EPECA30-2018
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03977376
- Acronym / sponsor ID
- EPECA30-2018 / EPECA30-2018
- Conditions
- Anxiety, Nurse-Patient Relations, Behavior
- Keywords
- anxiety, Urogical, Guide of Hosting, Comunication instrument, Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 26 May 2019 (actual)
- First posted
- 6 Jun 2019 (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 overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention.
Detailed description
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing communication instrument: a Guide of Hosting for urological scheduled patients for surgical intervention.
The purpose of the proposed project is to establish the feasibility and acceptability of this guide to decrease the anxiety in this patients, using a randomized clinical trial like a research design, which would test the effectiveness of this communication instrument in comparation to a control condition (patients without guide of housting).
To achieve the investigators specific aims, the investigator conducted a randomized clinical trial (n=50), with two groups: intervention group (with Guide of Hosting) and control group (which shows a control condition).
Valuation instruments were two validated scales: ESAS y HADS. Anxiety was the primary outcome variable assessed in the RCT; depression and pain were a secondary outcomes variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Guide of hostingValuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting. |
| Control | No intervention | –Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age limits: 18 years old.
- with hospital admission scheduled at 5ªA hospitalization service of the University Hospital of Guadalajara for surgical intervention with urological diagnosis
Key exclusion criteria (4 listed)
- patients with cognitive deficit.
- patients with recurrent insomnia problems
- without Spanish language proficiency
- patients that have participated in a clinical trial in the last three months.
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 |
|---|---|---|
| Guide of hostingGuide of hosting with information about hospitalization to decrease anxiety | Other | Intervention |
Primary outcome
Anxiety: Hospital Anxiety and Depression Scale (HADS)
Time frame: 4-5 months
To assess anxiety and depressive symptoms in a general medical population. There are 7 depression items measuring cognitive and emotional aspects of depression, predominantly anhedonia, intermingled with 7 anxiety items that focus on cognitive and emotional aspects of anxiety. Somatic items relating to emotional and physical disorders are excluded. With 14 items.
Anxiety: Edmonton Symptom Assessment System (ESAS)
Time frame: 4-5 months
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospilatation, with ratings ranging from 0 (none, best) to 10 (worst).
1 secondary outcome
Pain: Edmonton Symptom Assessment System (ESAS)
Time frame: 4-5 months
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 6 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Carmen Gracia Ruiz Garcia principal investigator
Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guide of hosting in people with Anxiety and Nurse-Patient Relations, run by University of Alcala 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 2 inclusion and 4 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 6 Jun 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?
Anxiety: Hospital Anxiety and Depression Scale (HADS) (time frame: 4-5 months). The study lists 2 primary outcomes in all. 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 6 Jun 2019.