Protocol summary

Summary
The purpose of this study was to investigate the effect of liaising nurse services on patients 'stress and the anxiety and stress of patients' family during transfer from the intensive care unit to the general ward. This is a semi-experimental and double-blind study in which 248 patients and families non-randomly selected from hospitals affiliated to Qom University of Medical Sciences. Blindness is such that subjects and data collector does not know who is in which group. To prevent the exchange of information between the intervention group and the control group, sampling was started from the intervention group. After completing the sampling from the intervention group, sampling from the control group started and continued until the end of the study. Subjects in the intervention group will benefit from liaising nurse services during the study, including counseling, support and facilitation of communication between the ICU and the general sector and the control group will receive only routine care. Inclusion criteria included: patient orientation to time, place and person, no known history of psychiatric, consent to participate in the study, not taking anti-anxiety drugs; and the age above 18 years. Exclusion criteria: Occurrence of unexpected events for the patient during the study (Patient dies); s/he should not have the desire to continue the clinical working trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072933998N2
Registration date: 2017-10-03, 1396/07/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Kurosh Jodaki
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9072
Email address
kjodaki@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a liaison nurse service on stress of patients and anxiety and stress of patients’ families after intensive care unit transfer.
Public title
The effect of a liaison nurse service on stress of patients and anxiety and stress of patients’ families after intensive care unit transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient should be admitted for at least 24 hours in ICU; being aware of time, place and person; The patient should be able to understand the contents in the Persian language; s/he should not have the history of proven mental diseases; s/he should not have severe visual and hearing disorders; s/he should have full consent for the study; no anti-anxiety medication consumption; the age group is over 18 years old. Exclusion criteria: Occurrence of unexpected events for the patient during the study (Patient dies); s/he should not have the desire to continue the clinical working trial.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 248
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli Street, Qom
City
Qom
Postal code
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
IR.MUQ.REC.1396.62

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention, two hours after intervention and 24 hours after intervention.
Method of measurement
Spielberger Anxiety questionnaire.

2

Description
Stress
Timepoint
Before intervention, two hours after intervention and 24 hours after intervention.
Method of measurement
Stress Visual Scale(VAS)

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, patients will receive routine care.
Category
Treatment - Other

2

Description
Intervention group: Liaison nurse Services will start from the beginning of decision for patient transfer from intensive care unit to the general ward and will continue for patients and families up to 24 hours of hospitalization. The Liaison nurse activity will be as follows based on the studies:* Physical and emotional care and support and training of the patient and his family: Receiving a report on the patient's physical condition from nurses during hospitalization in ICU, Communicating with the patient and initial evaluating the patient's needs. Explaining to the patient and family about the cause of the patient transfer, facilities and personnel, Daily visits by a Liaison nurse with the patient and family, Explaining to the family about the patient's current condition and recovery process, Family Education how to support the patient in the ward to reduce the anxiety and stress of the family and the patient.**Communicating between the intensive care unit and the general ward. Liaison nurse will inform nurses from the facilities in the intensive care unit, encouraging the ICU nurses to give a full report of patients to the head nurse, Trying to inform the departmental staff about the patient's transfer and his condition at least two hours before the transfer of the patient and during the transfer to the general ward. All patients’ body systems including respiratory, cardiovascular, renal, nervous and digestive status will be reviewed by the patient's nurse. And what about all the needs of the patient and his family will be taught in the department.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Qom
Full name of responsible person
Kurosh Jodaki
Street address
Shahid Beheshti Hospital, Shahid Chamran Street, Qom
City
Qom

2

Recruitment center
Name of recruitment center
Nekoei Hospital in Qom
Full name of responsible person
Mohammad Abbasi
Street address
Nekoei Hospital, Azar Street, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qom University of Medical Sciences
Full name of responsible person
Dr Saghafi
Street address
No. 83, Street No. 4, Safashahr Street, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qom 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
Qom University of Medical Sciences
Full name of responsible person
Kurosh Jodaki
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom.
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Lecture
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom.
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
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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