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The effect of nursing supportive program on anxiety in patients transferred from the ICU heart surgery to General ward.

Protocol summary

Summary
The purpose of this study was to determine the effect of Supportive Nursing Program, on the anxiety of patients transferred from Cardiac surgery Intensive Care Unit to the Public Unit. In this Quasi-experimental study, 68 patients whom are hospitalized in the cardiac surgery intensive care unit of Tehran hospitals, after a random sampling will enter into two intervention and control groups. Before starting the intervention, the patient`s anxiety will be measured by Spielberger State-Trait Anxiety Questionnaire, moreover the physical symptoms of anxiety (blood pressure, pulse and respiration) are also measured. While the patients in the Control group will receive only routine nursing care, patients in the Experience group, will use the Supportive Nursing Program, during the transfer process to the public unit, which is conducted by researcher nurse. Finally, again anxiety, and physical symptoms of anxiety will be measured and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401274443N7
Registration date: 2014-02-12, 1392/11/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-01-29, 1392/11/09
Expected recruitment end date
2014-04-29, 1393/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing supportive program on anxiety in patients transferred from the ICU heart surgery to General ward.
Public title
The effect of nursing supportive program on anxiety in patients transferred from the ICU heart surgery to General ward.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the patient should be hospitalized for the first time in intensive care unit, sick time, being aware of time, place and person, being in the above 18 years age group, the patient has ability to understand the contents in the Persian language, not to have history of known Psychiatric disease, patient`s transport to public unit, should be according to the unit`s routine and not to be emergency, during ICU stay no uncommon occurrence such as bleeding requiring retransfer to operation room, should be happened, at least 24 hours and a maximum of three days, should be be admitted to the ICU. Exclusion criteria were: Not to have desire to continue the clinical working trial, an unexpected event occurs during the transport process (such as pain, shortness of breath).
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
tehran
Postal code
1419733171
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
92/ص/130/2374

Health conditions studied

1

Description of health condition studied
circulatory and respiratory status
ICD-10 code
R00-R09
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems

Primary outcomes

1

Description
Anxiety and physical symptoms of anxiety.
Timepoint
before Time of transfer and 2 hours after being transferred to the ward.
Method of measurement
Spielberger Anxiety Questionnaire.blood pressure measuring devices.Chronometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: In the intervention group, Supportive Nursing Program during the transition process from cardiac surgery intensive care to the public ward would be used. Supportive Nursing Program begin from the treatment team`s decision to transfer the patient and continue until two hours after Patient`s settling in the public unit, and include researcher nurse presence, along with patient, from the decision of patient`s transfer the to the end of the transition process. Initially communication with the patient takes place (the researcher introduces himself to the patient, call patient's name and makes the initial connection with the patient in order to Warm up), then the initial assessment of the patient's specific needs, talking to patients regarding their disease process and selfcare techniques after the surgery, explaining the reasons and benefits of the transition from intensive care unit to the public unit, encourage the patient to talking about concerns and fears, answering the patient's probable questions is done in the next steps that the patient is being prepared for transmission, and in the host unit, familiarization the patient with the environment and personnel is done and if the patient is interested, family are allowed to visit.
Category
Other

2

Description
Control group: Usual nursing cares is used for the patients of control group during the transition process from the Cardiac surgery Intensive care unit to the Public unit.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Kuroshjodaki
Street address
North Kargar St
City
tehran

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kurosh jodaki
Street address
Imam Khomeini Hospital, DrMirkhani St, TohidSq
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr. Madadi
Street address
Keshavarz Blvd, Central Organization of Tehran University of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kurosh jodaki
Position
M.s of Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Dr.Mirkhani St, TohidSq
City
tehran
Postal code
1419733171
Phone
+98 21 6694 3187
Fax
Email
kuroshjodaki@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Phd Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, DrMirkhani St, TohidSq
City
tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
Email
zakerimo@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Master of Science in critical care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, DrMirkhani St, TohidSq
City
tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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