Determining the Effect of Religious Interventions on Life expectancy in Cancer Patients Under Chemotherapy
Design
The clinical trial included a control group, three blinded and randomized with a random table method. Religious interventions also take place, but the control group receives no intervention except routine nursing care.
Settings and conduct
This is an international study that will be conducted at Shahid Rahimi Hospital in Khorramabad city. Subjects undergoing chemotherapy will be included in the study after completing the informed consent form. After selecting the sample size, the units will be divided into two intervention and control groups. And international religious intervention sessions will be held for the intervention group. The data collection tool is a demographic questionnaire and Miller's standard of life expectancy questionnaire.In this study, the researchers, the patients participating in the study and the individual analyst will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Being in one type of cancer, having complete satisfaction to participate in the study, having at least one chemotherapy session, having reading and writing skills, having no mental illness, blindness and deafness in Aden.
exclusion criteria
Having chronic physical illnesses other than the mentioned disease, history of taking psychiatric and sedative drugs, history of using any drugs
Intervention groups
Intervention group: Patients with cancer undergoing chemotherapy and attending religious intervention sessions.
Control group: Patients with cancer undergoing chemotherapy and not attending religious intervention sessions.
Main outcome variables
The Life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040458N1
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
mehran naghibeiranvand
Name of organization / entity
Islamic Azad university khorramabad
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0351
Email address
mehranbeiranvandmsc@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of religious interventions on life expectancy in cancer patients undergoing chemotherapy
Public title
The effect of religious interventions on life expectancy in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The units are infected with a type of cancer
The units studied are aware of their illness
Do at least one chemotherapy session
Have complete satisfaction to participate in the study
Being Shia and Iranian
Having reading and writing skills
Not having mental illness
Lack of blindness and deafness
Exclusion criteria:
Having a chronic physical illness other than that
History of taking psychotropic and sedative drugs
History of using any drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
n the present study, the researchers, the patients participating in the study and analyzing the data, were kept blind. The research units will be informed that they have participated in the study, but they are not informed that in the intervention group Or control group. Also, a researcher and religious expert who hold religious intervention sessions are also not aware of the type of patient control or intervention group. Ultimately, the individual who analyzes the research data also comes from a group of patients participating in the study. In the study, the data were not coded as intervention and control group data Took.
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, Boroujerd Branch
Street address
Vice Chancellor for Medical Sciences, Islamic Azad University Boroujerd Branch,Modares Square,Modares st,Boroujerd
City
Borujerd
Province
Lorestan
Postal code
6915136111
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.IAU.B.REC.1399.012
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Life expectancy score by Miller's Life expectancy standard questionnaire
Timepoint
Measure the life expectancy before and after intervention
Method of measurement
Miller's Life expectancy Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, religious interventions were conducted in the form of three prayer and prayer sessions, centered on trusting in God, patience, appreciation and appreciation by a religious expert, and group discussions around the subject at the end of each session.
Category
Rehabilitation
2
Description
Control group: In this group, only routine care will be performed and no intervention will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi hospital
Full name of responsible person
Mehran Naghi Beiranvand
Street address
Shahid Rahimi Hospital, Mojahedin Islam St, Azadi Square, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
3817816645
Phone
+98 66 3312 0011
Email
mehranbeiranvandmsc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Mirdrikvand
Street address
Ayatollah Kamalvand University Complex,5 km of Khorramabad-Tehran road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 0025
Email
drikvand_r@yahoo.com
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
Islamic Azad University
Full name of responsible person
Mehran Naghi Bieranvand
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex.5 km of Khorramabad-Tehran road.
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 0011
Email
mehranbeiranvandmsc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Naghibeiranvand
Position
Mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad university khorramabad
City
Khorramabad
Province
Lorestan
Postal code
۶۸۱۷۸۱۶۶۴۵
Phone
+98 66 3312 0351
Fax
Email
mehranbeiranvandmsc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Naghibeiranvand
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex.5 km of Khorramabad Tehran Road
City
khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 663312001119
Email
mehranbeiranvandmsc@gmail.com
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
The data remains confidential with the researcher and, if necessary, provided to the participants in the study. It should be noted that data analysis is presented in tables and charts.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available