Determining the impact of feedback-based discharge training on the anxiety of family caregivers of patients admitted to the special care units of Shahid Rahmonun Hospital in Yazd in 1403
Design
The clinical trial has two intervention and control groups with randomized parallel groups in phase 2 on 76 patients.
Settings and conduct
After the announcement of the resident doctor in the ICU based on the start of the patient discharge process and education to the family, the demographic and anxiety questionnaires will be provided to them at first. For the control group, routine training during discharge is done verbally and in writing. For the intervention group, these trainings will be done in a feedback way.In each of the two studied groups, Spielberger's anxiety questionnaire will be completed by caregivers after the third training session, and the anxiety level will be obtained
Participants/Inclusion and exclusion criteria
A) Inclusion criteria
Patient:
1. Hospitalization of the patient in the intensive care unit
2. People who will be discharged with GCS less than 15
Intervention groups
For the control group, routine training during discharge is done verbally and in writing. For the intervention group, these trainings will be done in a feedback way. In each of the two studied groups, Spielberger's anxiety questionnaire will be completed by caregivers after the third training session, and the anxiety level will be obtained.
Main outcome variables
If feedback-oriented training has an effect on reducing the anxiety of caregivers, it can be suggested as an effective intervention in educational programs during the discharge of patients hospitalized in special care units of hospitals under the Ministry of Health, in order to reduce the anxiety of caregivers.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241229064205N1
Registration date:2025-02-06, 1403/11/18
Registration timing:registered_while_recruiting
Last update:2025-02-06, 1403/11/18
Update count:0
Registration date
2025-02-06, 1403/11/18
Registrant information
Name
maryam zeighamian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 9036
Email address
maryamzeighamian1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-29, 1403/10/09
Expected recruitment end date
2025-04-29, 1404/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Discharge Education with the Teach-Back Method on the anxiety of Family Caregivers of Patients Hospitalized in the Intensive Care Unit
Public title
The Effect of Discharge Education with the Teach-Back Method on the anxiety of Family Caregivers of Patients Hospitalized in the Intensive Care Unit
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization of the patient in the intensive care unit
People with GCS less than 15 will be discharged
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are initially selected according to the available method based on the entry and exit criteria, and then gradually, based on the table of random numbers, they are randomly assigned to the intervention and control groups.
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 Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
Tehran, Quds town (west), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Khorasgan
Province
Isfehan
Postal code
8916933367
Approval date
2025-01-06, 1403/10/17
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.472
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anxiety
Timepoint
Before training and after training
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teach-Back Method:Intervention group: feedback-oriented training: training to provide regular feedback to specific individuals. This can help them identify their strengths and weaknesses and improve their skills
Category
N/A
2
Description
Control group: Training during routine hospital discharge
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Dr. Rahnamun Hospital
Full name of responsible person
رضا قادریان
Street address
Farrokhi St
City
yazd
Province
Yazd
Postal code
۸۹۱۳۸۱۴۳۹۶
Phone
+98 35 3626 0001
Email
rahnamoon@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammad Mehdi Karimnejad
Street address
Yazd, Safia, Alam Square, Shohdai Anom Blvd., Islamic Azad University Complex
City
yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 6781
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Zeighamian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No45،Alley46،Shahid KhalilHasanBeigi Street
City
Yazd
Province
Yazd
Postal code
8916933367
Phone
+98 35 3724 9036
Fax
Email
maryamzeighamian1375@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Zeighamian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No45،Alley46،Shahid KhalilHasanBeigi Street
City
Yazd
Province
Yazd
Postal code
8916933367
Phone
+98 35 3724 9036
Fax
Email
maryamzeighamian1375@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Zeighamian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No45،Alley46،Shahid KhalilHasanBeigi Street
City
Yazd
Province
Yazd
Postal code
8916933367
Phone
+98 35 3724 9036
Fax
Email
maryamzeighamian1375@gmail.com
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
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