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出境医 / 临床实验 / Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial (EPECA30-2018)

Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial (EPECA30-2018)

Study Description
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.

Condition or disease Intervention/treatment Phase
Anxiety Nurse-Patient Relations Behavior Other: Guide of hosting Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: RCT
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 26, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.
 Other: Guide of hosting
Guide of hosting with information about hospitalization to decrease anxiety
No Intervention: Control
Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.
Outcome Measures
Primary Outcome Measures :
  1. 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.


  2. 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).


Secondary Outcome Measures :
  1. Pain: 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 hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
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Spain
EPECA
Guadalajara, Spain, 19005
Sponsors and Collaborators
University of Alcala
Investigators
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Principal Investigator: Carmen Gracia Ruiz Garcia Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE January 3, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019) 		Pain: 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 hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Official Title  ICMJE Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
RCT
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anxiety
  • Nurse-Patient Relations
  • Behavior
Intervention  ICMJE Other: Guide of hosting
Guide of hosting with information about hospitalization to decrease anxiety
Study Arms  ICMJE
  • Experimental: Intervention
    Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.
    Intervention: Other: Guide of hosting
  • No Intervention: Control
    Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2019) 		50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 26, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977376
Other Study ID Numbers  ICMJE EPECA30-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carmen Gracia Ruiz García, University of Alcala
Study Sponsor  ICMJE University of Alcala
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen Gracia Ruiz Garcia Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
PRS Account University of Alcala
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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