Determining the effect of spiritual counseling on the care burden of caregivers of the elderly with cancer
Design
Clinical trial with control group, randomized, phase 3 on 66 patients. Matlab software was used for randomization.
Settings and conduct
The sampling location is Khansari Hospital, Arak city, and each group includes 33 patients, who will be divided into control group and intervention group by simple randomization method, and each patient will be given a code.
Zarit 4 care burden questionnaire will be completed in two pre-test and post-test stages for both intervention group and control group before the implementation of the intervention.
For i.g, the spiritual counseling protocol of Baljani and colleagues will be implemented, and then, the questionnaires of the post-test phase will be implemented and the analysis process will be performed.
Participants/Inclusion and exclusion criteria
Entry requirements include consent to participate in the study
Age above 18 years
Literacy for reading and writing
The conditions of non-entry include lack of consent of the patient or companion in the study
Cancer patients with multiple chronic diseases, such as cancer with mental illness, diabetes, etc
Intervention groups
The intervention group of caregivers of the elderly with cancer who receive intervention
The control group of caregivers of the elderly with cancer who do not receive intervention
Main outcome variables
Carers' burden of care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230319057757N1
Registration date:2023-04-29, 1402/02/09
Registration timing:prospective
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Saeid Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3435 2823
Email address
nu.saeidmaleki1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual counseling on the care burden of elderly cancer caregivers.
Public title
"Investigating the effect of spiritual counseling on care giving burden"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Age above 18 years
Literacy for reading and writing
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will assign a back code to each volunteer, which divides the volunteers into two intervention groups (A) and control group (B) using the block randomization method using Matlab software, which was done by a statistician.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
A'lam Al Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.ARAKMU.REC.1401.339
Health conditions studied
1
Description of health condition studied
caregivers of the cancer patients
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
Reducing the care burden of caregivers of elderly patients with cancer
Timepoint
Before the intervention and 10 sessions after the intervention.
Method of measurement
Zarit et al. care burden questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Caregivers of the elderly with cancer will receive 10 sessions of spiritual counseling in a month and a half, two 60-minute sessions a week on Sundays and Tuesdays.
Category
N/A
2
Description
Control group: Caregivers of the elderly with cancer for whom no intervention will be implemented
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Specialized Educational and Therapeutic Center
Full name of responsible person
Parsa Rostami
Street address
The end of university street، Arak.
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3336 7500
Email
info_khansari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arak University of Medical Sciences
Street address
Alam El Hadi St., Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Saeid Maleki
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 3 Javadieh Alley, Javadieh Township, Shahid Mousavi St., Qaim Maqam St.
City
Arak
Province
Markazi
Postal code
3816996797
Phone
+98 86 3435 2823
Email
nu.saeidmaleki1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ameneh Yaghoobzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Markazi Province,
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Email
A.yaghoobzadeh@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Saeid Maleki
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 3 Javadieh Alley, Javadieh Township, Shahid Mousavi St., Qaim Maqam St.
City
اراک
Province
Markazi
Postal code
3816996797
Phone
+98 86 3435 2823
Email
nu.saeidmaleki1995@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