Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
EPECA30-2018
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jan 2019
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2019
CompletedFirst Submitted
Initial submission to the registry
June 2, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedJune 6, 2019
June 1, 2019
4 months
June 2, 2019
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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).
4-5 months
Secondary Outcomes (1)
Pain: Edmonton Symptom Assessment System (ESAS)
4-5 months
Study Arms (2)
Intervention
EXPERIMENTALValuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.
Control
NO INTERVENTIONValuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.
Interventions
Guide of hosting with information about hospitalization to decrease anxiety
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EPECA
Guadalajara, 19005, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Gracia Ruiz Garcia
Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- RCT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Máster Social-sanitary Science Investigation
Study Record Dates
First Submitted
June 2, 2019
First Posted
June 6, 2019
Study Start
January 3, 2019
Primary Completion
April 30, 2019
Study Completion
May 26, 2019
Last Updated
June 6, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share