Determining the Impact of Nursing Transmission from ICUs to General Sectors on Anxiety and Satisfaction of Patients and Their Families
Design
Clinical trials with community based and pragmatic control group, with parallel groups, without blindness, randomized
Settings and conduct
This study will be carried out in Imam Khomeini Hospital of Ahvaz . According to the randomization table, the patients in the control and intervention group will receive the Nursing Transmission protocol on the intervention group and the routine program in the control group.
Participants/Inclusion and exclusion criteria
Patients and their families who are admitted to the intensive care unit and ordered to be transferred to the general care unit and are alert to complete and mental health; patients who suffer from complications such as respiratory distress and reduced consciousness before they are transferred. Study will be excluded.
Intervention groups
In the intervention group, anxiety was measured once a day using the Spielberger Anxiety Inventory and then the transmission protocol, which included the training required for measuring the need of the patient and his family and the presence of the nurse before, during and after the transfer, and one time 24 hours after the transfer is measured. The satisfaction questionnaire is completed 24 hours after transplantation by the patient and his family in the intervention group. The research intervention involves the implementation of this nursing transfer protocol and will be received in the routine care control group, and only the Spielberger questionnaire will be completed once before the transfer and 24 hours after the transfer by the patient and the main carer.
Main outcome variables
Reducing anxiety; increasing satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180210038685N1
Registration date:2018-05-09, 1397/02/19
Registration timing:registered_while_recruiting
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Somayeh Alboativi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2114
Email address
kishsami29@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Nursing Nursing Transmission from ICUs to General Sectors on Anxiety and Satisfaction of Patients and Their Families
Public title
Investigating the Impact of Nursing Nursing Transmission from ICUs to General Sectors on Anxiety and Satisfaction of Patients and Their Families
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old (to be considered an adult)
Full vigilance (Glasgow score 15)
Do not have a history of admission to the intensive care unit.
No history of psychological problems or anxiety disorders
Not to be a healthcare professional.
Exclusion criteria:
The patient has complications such as respiratory distress or reduced consciousness or death before the transfer.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Random selection using randomized blocked blocks with block size 4 (using a random permutation table), that is, in the intervention group, 106 persons and 106 in the control group. A randomized list is provided by a statistician. The intervention group, according to a randomized list, is assigned by a person outside the study according to the corresponding codes in the closed envelopes, and then assigned to any disease that is included in the study.
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 Ahwaz University of Medical Sciences
Street address
Golestan St, Medical Sciences Blvd, Ahvaz, Khuzestan Province, Iran
City
َAhvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.AJUMS.REC.1396.928
Health conditions studied
1
Description of health condition studied
Anxiety of Transition
ICD-10 code
Z80-Z99
ICD-10 code description
Persons with potential health hazards related to family and personal history and certain conditions influencing health status
Primary outcomes
1
Description
Anxiety
Timepoint
Complete the Spielberger questionnaire before and 24 hours after the transfer
Method of measurement
Spielberger Questionnaire
2
Description
Satisfaction
Timepoint
24 hours after the Performance of the nursing transfer protocol
Method of measurement
Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The research intervention involves the implementation of a nursing protocol that is designed by the researcher and includes the following steps: firstly, the researcher, along with the two researcher's assistance, will provide the necessary training in the public sector in order to measure the patient's needs and the family's needs. and the nurses before, during and after the transfer and complications for the prevention and Czech vital signs and systematic examination of the patient at each visit, care more specialized nursing intensive care unit, as well as education, rehabilitation and rehabilitation in case It will be done individually, verbally and face-to-face The face and care will be followed up by telephone with the patient nurse in the General Department. After the third visit, Spielberger anxiety inventory and patient satisfaction questionnaire filled out by the patient and family.
Category
Other
2
Description
Control group: routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Somayeh Alboativi
Street address
Azadegan St(24 meters St),Not reaching the Black Bridge ( Shahid Ahwazian Str), Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
kishsami29@gmail.com
Web page address
http://www.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan St, Medical Sciences Blvd, Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61375-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
alboatvi.s@ajums.ac.ir
Web page address
http://www.ajums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All details of the data will be shared without the identification of the person being investigated by maintaining ethical principles.
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
It will be accessible to everyone
Under which criteria data/document could be used
A certain condition will not be considered at this time.
From where data/document is obtainable
Ahwaz University of Medical Sciences located in Golestan Blvd. Ahwaz, with reference to the library of the Faculty of Nursing and Midwifery of this university and will be accessible only in person.
What processes are involved for a request to access data/document
Only by visiting the Faculty of Nursing and Midwifery of Ahwaz University of Medical Sciences and presenting a valid identification card will be available.