Protocol summary

Study aim
Determining the effect of of a family-centered education program on care burden in caregivers of burn victims referring to the emergency room of Shahid Motahari Medical Education Center.
Design
This study is a semi-experimental study with two groups. each group will consist of 40 patients and the study will have 3 phases of continuous sampling. In the end statistical analysis will be done with 16th version of SPSS statistical software and in two parts of descriptive statistics and inferential statistics
Settings and conduct
Research environment: Emergency Department of Shahid Motahari Medical Education Center / sampling method: Continuous / caregivers of the control group will complete the questionnaires 2 to 3 days after hospitalization and one month after discharge(Family-oriented education according to the cadre3)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Burns below 30% and no indication for hospitalization Exclusion criteria: Death during the study
Intervention groups
Family-oriented education program for the caregivers of the intervention group consists of four interactive lecture sessions which will provide information about the process of burn injuries, how to care for the wounds caused by it, proper nutrition for burn victims, long-term effects of the burn (wound scars and mental complications) and how to care for them, how to adapt with the complications of burns and information about the proper time of referral. These sessions will be 45 to 60 minutes long. On the other hand, the control group will undergo the routine education program of the department
Main outcome variables
Relieving the stress of caregivers will lead to a more efficient care, shorter recovery period, reduction of the complications, active involvement of the patients and their families in the care process and finally reduction the care burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240714062428N1
Registration date: 2024-11-11, 1403/08/21
Registration timing: registered_while_recruiting

Last update: 2024-11-11, 1403/08/21
Update count: 0
Registration date
2024-11-11, 1403/08/21
Registrant information
Name
fatemehsadat Tajadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3356 8297
Email address
fatemehsadattajzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a Family-centered Education Program on Care Burden in caregivers of burn victims
Public title
Investigating the effect of a family-centered education program on care burden in caregivers of burn victims
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Client: Patients older than 18 years old Being able to read and write absence of any self-reported chronic and mental disorders or self-immolation Patients with Burns below 30% and no indication for hospitalization Patients with second degree burns Watchful: Patients older than 18 years old Ability to attend in all of the meetings Want to attend all meetings Primary caregiver(carer) of the patient Patient’s immediate family members
Exclusion criteria:
Death during the study Resignation in the middle of the study Patients who get transferred to another treatment facility Caring for another family member other than the person with burns
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The sampling will be done by convenient method, and at first people will enter the control group. After completing the control group sample, sampling will continue to complete the intervention group. In order to blind and prevent leakage of information and content of educating sessions to the control group, the visit time for the intervention group is on even days, and for the control group, will be on odd days (Sunday, Tuesday, Thursday).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences Sciences
Street address
call 3/plate 194/corner of Tofangchi Alley/Hadadadal Street/17th Shahrivar South Street/Khorasan Square/Iran
City
Tehran
Province
Tehran
Postal code
1179936484
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.IUMS.REC.1403.277

Health conditions studied

1

Description of health condition studied
Care burden in caregivers of burn victims
ICD-10 code
L80-L99
ICD-10 code description
Other disorders of the skin and subcutaneous tissue

Primary outcomes

1

Description
Family-centered education program for the intervention group
Timepoint
2 - 3 days after the patient is hospitalized / after providing training sessions
Method of measurement
Educational content

Secondary outcomes

1

Description
Care burden in caregivers
Timepoint
2 to 3 days after the patient's hospitalization / after providing training sessions
Method of measurement
Zarit’s Questionnaire of Care Burden /scores ranging from 0 to 20 mean low or no care burden, scores ranging from 21 to 40 mean moderate care burden and scores ranging from 41 to 88 mean severe care burden in caregivers.

Intervention groups

1

Description
Family-oriented education program for the caregivers of the intervention group consists of four interactive lecture sessions which will provide information about the process of burn injuries, how to care for the wounds caused by it, proper nutrition for burn victims, long-term effects of the burn (wound scars and mental complications) and how to care for them, how to adapt with the complications of burns and information about the proper time of referral. These sessions will be 45 to 60 minutes long
Category
Lifestyle

2

Description
Control group: At first (2 - 3 days after hospitalization) and one month after discharge, they complete the questionnaires
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Medical Education Center
Full name of responsible person
Fatemeh Sadat Tajzadeh
Street address
First floor، Bahonar dead end، Fruit alley، Haddadal St، 17 Shahrivar South Street، Khorasan Square
City
Tehran
Province
Tehran
Postal code
1179936484
Phone
+98 21 3356 8297
Email
Fatemehsadattajzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Layla Amini
Street address
Rashid Yasemi Street/above Vanak Square/Vali Asr Street (AJ)/Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1708
Email
amini.l@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Tajzadeh
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Number 1/Bahoner Dead End/Miveh-chi Alley/17 South Shahrivar St/Khorasan Square/Tehran/Iran
City
Tehran
Province
Tehran
Postal code
1179936484
Phone
009821335683297
Email
fatemehsadattajzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz seyedoshohadaei
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences/Rashid Yasemi St/above Vanak Square/Vali Asr St. (AJ)/Iran
City
Tehran
Province
Tehran
Postal code
88201978
Phone
+98 21 8888 2886
Email
saydshohadai@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Tajzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 3/Number 194/corner of Gunner alley/Haddad Adel St/17 Shahrivar South Street/ Khorasan Square
City
Tehran
Province
Tehran
Postal code
1179936484
Phone
+98 21 3356 8297
Email
fatemehsadattajzadeh@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
Yes - There is 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
Consent letter for participation in the study plan to determine family-centered education on the care burden of caregivers of burn patients referring to the emergency department of Shahid Motahari Medical Education Center. Dear Sir/Madam You are hereby invited to participate in the aforementioned research. The information related to this research is provided in this service sheet and you are free to participate or not participate in this research. You don't have to make an immediate decision and you can ask your questions to the research team and consult with anyone you want to make a decision. Before signing this consent form, make sure that you have understood all the information in this form and that all your questions have been answered. Name of research supervisor: Mahnazseyedoshohadaee.Student: Fatemeh Sadat Tajzadeh know that the goals of this research are: Holding training sessions with the content of the burn process, how to care for the wound, etc., to determine the impact on the care burden of burn victims 2. I know that my participation in this research is completely voluntary and I am not forced to participate in this research. I was assured that if I am not willing to participate in this research, I will not be deprived of the usual diagnostic and therapeutic care and my therapeutic relationship with the treatment center and my treating doctor will not be disturbed. 3.I understand that even after agreeing to participate in the research, I can withdraw from the research whenever I want, after notifying the administrator, and my withdrawal from the research will not prevent me from receiving the usual medical services. 4. My cooperation in this research is as follows: Completing the questionnaire of demographic information including age, gender, etc. and the care burden questionnaire related to the research Participating in 4 training sessions with the content of information about the burn process, how to take care of the wound, proper nutrition, possible long-term effects of the burn (scar care, psychological complications, etc.), how to adapt to the complications of the disease, the time of re-referral 5. The possible benefits of my participation in this study are as follows: The readiness of caregivers to provide care to burn patients, which is effective in improving the quality of life of patients and solving their educational needs and questions. 6. Possible damages and complications of participating in this study are as follows: The researcher does not mention complications and harm. 7. If I do not want to participate in the study, the usual treatment method will be offered to me, the benefits and side effects of which are as follows: The benefits of participating in the exam, benefiting from training sessions with the mentioned content for caregivers and solving the concerns and questions that arise for them in the way of caring for burn patients. In case of unwillingness to participate in the study, the knowledge and information necessary to provide care for burn patients may not be provided. 8. I know that the people involved in this research have kept all the information related to me confidential and they are only allowed to publish the general and group results of this research without mentioning my name and details. 9. I understand that the research ethics committee can have access to my information for the purpose of monitoring the observance of my rights. 10. I understand that none of the costs of research interventions as described below will be my responsibility. All training sessions for caregivers are free of charge. 11. Mrs. / Mr. ................... was introduced to me for answering and I was told that whenever there is a problem or question related to participation in the mentioned research I will share with them and ask for guidance. His address and landline and cell phone numbers were presented to me as follows: 12. I understand that if during and after conducting the research any problem, both physical and mental, occurs to me due to participating in this research, the treatment of complications, its costs and the related compensation will be the responsibility of the administrator. 13. I know that if I have any problems or objections regarding the participants or the research process, I can contact the Research Ethics Committee of Iran University of Medical Sciences at the address: Tehran, Hemat Highway between Chamran and Sheikh Fazlullah, Central Headquarters Building of Iran University of Medical Sciences. , 5th floor, room 503, refer and present your problem orally or in writing. 14. This information and informed consent form is prepared in two copies and after signing, one copy will be at my disposal and the other copy will be at the administrator's disposal. I have read and understood the above-mentioned items, and based on that, I declare my informed consent to participate in this research. Participant's signature: Participant contact number: I ……………… consider myself obliged to implement the obligations related to the executive in the above provisions and I undertake to ensure the rights and safety of the participants in this research.
When the data will become available and for how long
Access started in 1404
To whom data/document is available
researchers
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
fatemehsadattajzadeh@gmail.com
What processes are involved for a request to access data/document
Message to email uploaded
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