Objectives of the study: Comparing the effects of "controlled visitation" and "limited visitation" on the anxiety levels of patients admitted to CCU of "Shahid Rajaee Hospital of Gachsaran".
Design: This study is a after and before quasi-experimental research with a control group.
Study population: patients admitted for angina (pectoris) to CCU of "Shahid Rajaee Hospital of Gachsaran" who are conscious with no history of psychiatric illness or psychoactive drug abuse.
Patient group: 60 patients who meet the above mentioned criteria will be selected for this study.
Intervention: 30 patients selected randomly from the patient group will be allowed to have "controlled visitation" twice daily for one hour and their anxiety level will be measured before and after intervention using Spielberger Inventory. In the controlled group the "limited visitation" policy will be applied which is routinely applied in CCU of "Shahid Rajaee Hospital of Gachsaran" and their anxiety levels will be measured during the first twelve hours of admission and 48 hours after it. Finally the anxiety levels of the patients in the intervention and control group will be compared.
Outcome: patient anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110524898N1
Registration date:2016-08-27, 1395/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-27, 1395/06/06
Registrant information
Name
somaye bashti
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3333 5450
Email address
s.bashti@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Committee of Ardabil University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of limited and controlled visitation on the anxiety of patients admitted to the cardiac critical care unit
Public title
Comparison of the effects of limited and controlled visitation on anxiety of patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The subject is:
Able to communicate; Conscious and aware of time, place and person; Clinically diagnosed with angina (pectoric) and admitted for it; Willing to participate.
Exclusion criteria:
The patient:
Has a history of psychiatric illness or psychoactive drug abuse; Is likely to be admitted to CCU in less than 24 hours; Is unable to comply with the protocol of this study; Is moved from a different ward.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil, Veterans Square, University Avenue, University of medical sciences
City
Ardabil
Postal code
5618953141
Approval date
2015-10-27, 1394/08/05
Ethics committee reference number
ir.arums.rec.1394.58
Health conditions studied
1
Description of health condition studied
Angina (Pectoris)
ICD-10 code
125-120
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and 48 hours after it
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: 30 patients selected randomly from the patient group will be allowed to have "controlled visitation" twice daily for one hour and their anxiety level will be measured before and after intervention using Spielberger questionnaire.
Category
Other
2
Description
In the control group the "no visitation" policy will be applied which is routinely used in CCU of "shahid rajaee hospital of gachsaran" and their anxiety levels will be measured during the first twelve hours of admission and 48 hours after it. Finally the anxiety levels of the patients in the intervention and control group will be compared.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital of Gachsaran
Full name of responsible person
Masoumeh Aghamohamadi
Street address
Previous Building Health Region, Between Saddi and Hafez Sq., Shohada Highway, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Ardabil University of medical sciences
Full name of responsible person
Masoumeh Aghamohammadi
Street address
Previous Building Health Region, Between Saddi and Hafez Sq., Shohada Highway, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Ardabil University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of medical sciences
Full name of responsible person
Somaye Bashti
Position
student of MSC in critical care nursing
Other areas of specialty/work
Street address
Janbazan Sq., Daneshgah Street, Ardabil University of medical sciences