Definition of spiritual reminiscence on depression and spiritual health in cancer patients
Design
The study population include cancer patients who are referred to chemotherapy centers of Shahrood and Gorgan. Sample size is 120. Sampling will be carried out using the available sampling method and assignment of research units to intervention and control groups by blocking method. Depression and spiritual health will be measured using the questionnaires. In intervention group, the psychiatric nurse will intervene under six sessions. Then the variables are measured immediately after intervention in both groups.
Settings and conduct
Chemotherapy centers in Shahrood and Gorgan, Iran. The person collecting information before and after the intervention and analyzer are blinde.
Participants/Inclusion and exclusion criteria
Final diagnosis of cancer by the doctor; no history of physical disabilities before occurring cancer; interested in participating in the research project; no history of psychiatric disorder; defined cancer stage; under chemotherapy; ability to answer questions; do not take medications that affect responsiveness.
Intervention groups
In the intervention group, there is spiritual reminiscence and the second group is also a control group and no interventions will be performed in this group. Before the intervention, the information are collected using demographic characteristics of the Beck's deppression and Palutzian-Elison's spiritual health questionnaires. Then the sessions of intervention during 6 sessions (1: meaning of life; 2: relationships-isolation; communicating; 3: hopes, fears and concerns; 4) aging and excellence; 5: spiritual and religious beliefs; 6: spiritual and religious practices) Will be held by the psychiatric nurse for the intervention group. Immediately after the intervention, the variables will be measured.
Main outcome variables
Depression; spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180728040617N2
Registration date:2018-10-21, 1397/07/29
Registration timing:registered_while_recruiting
Last update:2018-10-21, 1397/07/29
Update count:0
Registration date
2018-10-21, 1397/07/29
Registrant information
Name
Seyedmohammad Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3811
Email address
mirhoseinim@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-05, 1397/07/13
Expected recruitment end date
2019-01-06, 1397/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spiritual reminiscence on spiritual health and depression in cancer patients
Public title
Effect of spiritual reminiscence on spiritual health and depression in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Final diagnosis of cancer by the doctor
No history of physical disabilities before occurring cancer
Interested in participating in the research project
No history of psychiatric disorder
The stage of the disease is defined for each member of the sample
Under chemotherapy
The ability to communicate verbally
Do not take medications that affect responsiveness
Exclusion criteria:
Immigration; patients who will be discharged or died during the study
Cardiopulmonary resuscitation during the study
Failure to answer more than percent(15%) of the questionnaire asks
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize by quadrilateral blocking
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who collects the information before and after the intervention and the analyst from the group of people unaware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, 7th tir Square
City
Shahroud
Province
Semnan
Postal code
36147 73947
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
IR.SHMU.REC.1397.123
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, after intervention
Method of measurement
Beck Deppression Inventory
2
Description
Spiritual health
Timepoint
Before intervention, after intervention
Method of measurement
Palutzian-Elison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: as a group counseling program based on spiritual reminiscence. Spiritual reminiscence intervention sessions will be held in 6 sessions for the intervention group by the psychiatric nurse with the necessary skills in this area. Spiritual recollection program will be held at a meeting of 60 to 90 minutes. The psychiatrist leads the meeting. This program will include the following topics for each week: Week 1: The meaning of life; Week 2: Relationships-Isolation; Communicating Week 3: Hope, Fear and Concern 4: Aging and Exhortation 5: Spiritual and Religious Beliefs Week 6: Spiritual and religious practices
Category
Behavior
2
Description
Control group: in this group, routine chemotherapy interventions, such as chemotherapy, will be conducted on various sections of the department that will be performed for all patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Shahrood
Full name of responsible person
Seyed Mohammad Mir Hosseini
Street address
Tehran street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
smohammadmh@gmail.com
2
Recruitment center
Name of recruitment center
5th Azar Hospital
Full name of responsible person
Ali Abbasi
Street address
5th Azar Street
City
Gorgan
Province
Semnan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
abbasi_msn@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Tehran street
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Vice chancellor of Research and technology of Shahroud University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mir Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
smohammadmh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Abbasi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
abbasi_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mir Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
smohammadmh@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