Comparison of the Effectiveness of Scheduled Visits of Family Caregivers on incidence and severity of Delirium among Patients admitted to ICU and their caregivers' anxiety
Determining the effect of scheduled visit of family caregivers on incidence and severity of delirium among patients admitted in ICU and their caregivers anxiety
Design
A Randomized Controlled Clinical Trial
Settings and conduct
20 participants will be randomly assigned to the intervention group and 20 to the control group. The data will be collected by NEECHAM scale and Spielberger anxiety questionnaire.The place of study is the Intensive care units
Participants/Inclusion and exclusion criteria
Conscious patients with Glasgow Coma Index score <13
Willingness and consent to participate in the study
Patients who are not completely isolated
No delirium and cognitive disorders in the patient before entering the study
Not taking anti-anxiety drugs at the time of starting the intervention by the caregiver
Intervention groups
Intervention group: In the first session, the anxiety level of family caregivers will be assessed using the Beck Anxiety Inventory. Family caregivers will be present at the patient's bedside for 15 minutes from 16:00 to 17:00 and 21:00 to 22:00 and will communicate with the patient according to the defined protocol. In the fifth day, their anxiety level will be checked. Before the presence of the caregiver, immediately after leaving the patient's bed, 60, 120 and 180 minutes after the presence of the caregiver, the patient is checked with the NeeCham scale in terms of the incidence and severity of delirium.
Control group: In the first session, the anxiety level of the patient's family caregivers will be assessed. Meetings are done according to the routine of the educational-therapeutic center.The sequence of checking the incidence and severity of delirium will be performed using the NeeCham scale as in the intervention group.
The anxiety level of caregivers is measured On the fifth day.
Main outcome variables
1-Incidence and severity of delirium
2- Caregivers anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008359N3
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Farnaz Rrahmani
Name of organization / entity
Tabriz nursing and midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
frahmani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Scheduled Visits of Family Caregivers on incidence and severity of Delirium among Patients admitted to ICU and their caregivers' anxiety
Public title
The effect of scheduled visit of family caregivers on incidence and severity of delirium among patients admitted in ICU and their caregivers anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious patients with Glasgow Coma Index score <13
Willingness and consent to participate in the study
Patients who are not completely isolated
No delirium and cognitive disorders in the patient before entering the study
Not taking anti-anxiety drugs at the time of starting the intervention by the caregiver
Exclusion criteria:
Unavailability of primary caregiver
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be 40 male and female conscious patients hospitalized in Intensive care units and will be selected through convenience sampling. At the beginning of each work shift, the researcher will be informed about the availability of beds and the possible admission of new patients by visiting in person or by calling the officials of the special departments. The participants in the groups will be assigned to the intervention and control groups using the random block method with 4 and 6 blocks and with a ratio of 1:1. Stratification will be done based on the sampling location (Imam Reza, Sinai and Razi Hospital). In order to hide the allocation, the type of allocation will be written on paper and placed in opaque envelopes that are numbered consecutively (Allocation Concealment). The envelopes will be opened in order and by a person not involved in sampling. If the participant is included in the intervention group, a member of the patient's family who meets the family caregiver entry criteria will be selected as the patient's main caregiver to participate in the intervention. Then, the communication protocol and meeting schedule will be taught face-to-face and in writing to the family caregivers of the intervention group.
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 Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Sought shariatee street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
347-51745
Approval date
2023-08-07, 1402/05/16
Ethics committee reference number
IR.TBZMED.REC.1402.352
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Incidence and severity of Delirium
Timepoint
Before the intervention, 60, 120 and 180 minutes after the intervention for 5 consecutive days
Method of measurement
The Neelon and Champagne Confusion Scale(NeeCham)
2
Description
Anxiety score of the main caregiver
Timepoint
The first day before the intervention, the fifth day after the intervention
Method of measurement
Speilberger State – Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After determining the main caregiver, the objectives and method of the study are explained to them. Then, in a briefing session, the necessary training is provided regarding how to perform the intervention, and then the materials are given to them in the form of a booklet. After the coordination of the researcher with the patient's nurse and the shift manager, the family caregivers of the patients are present at the patient's bedside for 15 minutes from 16:00 to 17:00 and from 21:00 to 22:00 and communicate with the patient according to the defined protocol. During the entire duration of the meeting, the researcher is a non-participant observer of the meeting and examines the caregiver's performance during the meeting. If necessary, after the completion of the intervention, training will be given to the caregiver again so that the method of implementing the intervention can be modified in the next meeting. Also, before the presence of the caregiver at the patient's bedside, immediately after leaving the patient's bedside, 60, 120, and 180 minutes after the presence of the caregiver, the patient is checked with the NeeCham scale in terms of the incidence and severity of delirium.
Category
N/A
2
Description
Control group: meeting in this group is done according to routine meetings. The researcher was present at the patient's bedside at the appointed time for the visit and immediately before and after the presence of the caregiver, 60, 120 and 180 minutes after the presence of the caregiver, as in the intervention group, examines the patient with the NeeCham scale in terms of the incidence and severity of delirium. .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Tabriz
Full name of responsible person
Farnaz Rahmani
Street address
Golgasht St, Imam Reza Educational and Medical Center of Tabriz, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7059
Fax
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Golgasht St, Central Building No. 2, Research and Technology Vice-Chancellor, Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Rrahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Sought shariate street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 3479 6969
Email
frahmani@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Rrahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Sought shariate street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciencesو, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
frahmani@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Rrahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Sought shariate street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
347-51745
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
frahmani@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to primary (incidence and severity of delirium) and secondary (family caregivers' anxiety) outcomes can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The researchers working in academic institutions
Under which criteria data/document could be used
The use of documents is allowed only for scientific purposes and the publication of information for the advancement of science.
From where data/document is obtainable
Farnaz Rahmani, Assistant professor in Tabriz Nursing and Midwifery Faculty, Tabriz University of Medical Sciences, Tabriz, Iran. Tell: +984134796770, Cellphone: +989143002439
Email: frahmani@tbzmed.ac.ir
What processes are involved for a request to access data/document
Send the reason for the request to access the data via email.