The impact of Intensive Care Unit liaison nurse Services on anxiety of patient's family caregivers after discharge from ICU
Design
Eligible specimens are assigned to two intervention and control groups using the stratified random allocation method and using the random number table in the form of 1: 1, which is first sampled from the control group and then sampled from the intervention group.
Settings and conduct
After obtaining the written consent of the participants, before entering the general ward and after the order of discharge by the doctor, and after being transferred from the special ward, the Spielberger questionnaire will be completed by interview or self-report by the family caregiver. In the intervention group, in addition to routine care, participants are provided with interface nurse services.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1.No history of previous hospitalization of family members and care of another patient 2. No history of known neurological disease 3. Be the main and direct caregiver of the patient and a first-degree relative 4.Willingness to enter the study 5.Score more than 20 based on the Spielberger Anxiety Scale 6.Age over 18 years 7.Hospitalization of the patient in the intensive care unit for at least 24 hours 8.Lack of background in medicine- Exclusion criteria:1. Reluctance to continue cooperation in the study
2.Changing the caregiver during the study 3.Sending the patient to another hospital, direct discharge home or discharge with personal consent
4.Instability of the patient's hemodynamic status
5. Occurrence of special circumstances so that the liaison nurse is not able to manage it
6. Re-admission of the patient in the intensive care unit during the study
Intervention groups
In control group, family caregiver, routine care and intervention group receive liaison nurse services.
Main outcome variables
Family caregiver anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100609004129N4
Registration date:2020-07-15, 1399/04/25
Registration timing:registered_while_recruiting
Last update:2020-07-15, 1399/04/25
Update count:0
Registration date
2020-07-15, 1399/04/25
Registrant information
Name
Shirin Hasanvand
Name of organization / entity
Lorestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66 1321 3759
Email address
hasanvand.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of Intensive Care Unit liaison nurse Services on anxiety of patient's family caregivers after discharge from ICU
Public title
The impact of Intensive Care Unit liaison nurse Services on anxiety of patient's family caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of previous history of admission of family members and care of another patient
No history of known psychiatric illness
The desire to enter the study
Score more than 20 on a scale of Spielberger
Age over 18 years
Patient Hospitalization to the ICU for at least 24 hour
No background in the medical field
The main and direct caregiver and the first-degree relatives
Exclusion criteria:
Having a background in the medical field
Patient hospitalization for less than 24 hours
Age less than 18 years
Score less than 20 based on the Spielberger Anxiety Scale
Unwillingness to enter the study
Do not be the direct carer of the patient and a first-degree relative
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, each section is considered as a floor, and within each floor, a series of non-probabilistic sampling appropriate to the volume is used. Eligible specimens are classified using the stratified random allocation method (classes are based on the reason for admission, the patient's gender, and level of education) and are assigned to the two groups of intervention and control using the 1: 1 random number table. Inside each floor, random return blocks are used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Kamalvand; Khorramabad-Tehran highway
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.LUMS.REC.1398.120
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Before and after intervention
Method of measurement
Spielberger Anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family caregivers of patients who can be transferred from the intensive care unit who receive the services of a liaison nurse..These services include assessing the patient's care needs and initial visit, assessing the general ward in terms of facilities and equipment, preparing the patient (answering possible questions, explaining the cause and advantage Transfer), coordination with the destination department, introducing the patient to the ward nurse, providing advice to the ward nurses on demand and training to the patient and family regarding nutrition, skin care and patient catheters, etc
Category
Other
2
Description
Control group: The family receives routine care (receiving information about the process of transferring and accompanying the patient and the family during the transfer to the general ward by the delivery nurse) and the general nurse is responsible for accepting the patient according to the routine of the ward (receiving information about the patient's condition and required measures). Is responsible.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi Hospital
Full name of responsible person
Shirin Hasanvand
Street address
Khorramabad - Boroujerd Road; University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0155
Fax
+98 66 3312 0140
Email
publicrelation@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
ebraham Fallahi
Street address
Khoram Abad-Boroujerd Highway, Lorestan University of Medical Sciences
City
خرم آباد
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shrin Hasanvand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorram Abad-Boroujerd Road, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0140
Email
hasanvand.sh1390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shirin Hasanvand
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 1321 3759
Fax
+98 66 1620 0140
Email
hasanvand.sh@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shirin Hasanvand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 1321 3759
Fax
+98 66 1620 0140
Email
hasanvand.sh@lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Failure to complete the study No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available