Determining the effect Of Spiritual Consultation On The psychosocial adjustment in patients with Cancer
Design
A randomised trial with two groups of intervention and a control group, community-based and pragmatic, with parallel groups
Settings and conduct
This study will be performed on cancer patients in Hamedan. Participants are randomly divided into equal intervention and control groups. 8 sessions of spiritual counseling are provided for members of the intervention group.
Participants/Inclusion and exclusion criteria
Entry requirements: Cancer disease
Non-entry terms: Being in the end stage of cancer disease
Intervention groups
Intervention group: The spiritual counseling, which is based on Islamic approach will be conducted in individual sessions for a period of 45 to 60 minutes in 8 sessions.
Control group: The control group will receive only routine nursing care at the hospital and will not receive counseling.
Main outcome variables
Psychosocial adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038377N3
Registration date:2018-07-14, 1397/04/23
Registration timing:registered_while_recruiting
Last update:2018-07-14, 1397/04/23
Update count:0
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
shadi asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3222 6958
Email address
sh.asgari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect Of Spiritual Consultation On The psychosocial adjustment in patients with Cancer
Public title
The effect Of Spiritual Consultation On The psychosocial adjustment in patients with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with passing at least 4 months of diagnosis.
the ability to talk
Being Muslim and Shiia
Exclusion criteria:
being at the end stage of the cancer
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two intervention and control groups with using the table of random numbers.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Facing the Mardom Park, Hamedan Town
City
Hamadan
Province
Hamadan
Postal code
6571915457
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.170
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Disseminated malignant neoplasm, unspecified
Primary outcomes
1
Description
Psychosocial adjustment
Timepoint
The first stage, before the start of the intervention, and the second stage 8 weeks after the intervention
Method of measurement
Psychosocial Adjustment with Illness Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The spiritual counseling, which is based on Islamic approach will be conducted in individual sessions for a period of 45 to 60 minutes in 8 sessions.
Category
Other
2
Description
Control group: The control group will receive only routine care at the hospital and do not receive counseling.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Abbasi
Street address
Shahid Beheshti Hospital, Ghaem sqr, Hamadan
City
Hamaden
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3838 0704
Fax
+98 81 3838 1035
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Facing the Mardom Park, Hamedan Town
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
umsha.asgari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Fax
Email
Umsha.asgari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
Umsha.asgari@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