Determine the effect of spiritual care on the hope and spiritual well-being of cancer patients
Design
This study is a clinical trial that has control and intervention group and will be done without blinding. Participants fall into the groups by block random allocation. The number of samples, with a drop of 10%, is projected to be 88. After the formation of the groups, the intervention of the spiritual care will be carried out in accordance with the Bussing protocol. The data were collected through two questionnaires of hope and a questionnaire of Pulotzin and Ellison, and data analysis was done using SPSS version 21.
Settings and conduct
The way of spiritual care intervention is based on the Bussing et al. (2010) protocol in four main religious areas (Excellence), being (meaning and purpose), emotional (relaxation) and social (communication) in 5 sessions, 2 hours before starting chemotherapy in the department Will be executed by the project executives. The duration of each session varied between 45 and 60 minutes.The location of the study is Shahid Rajaee Hospital in Yasuj
Participants/Inclusion and exclusion criteria
The population of this study is cancer patients referred to the chemo department of the Shahid Rajaie Hospital in Yasuj in 1396-97.
The criteria for entering the study include a definitive diagnosis of cancer by the oncologist, chemotherapy, age range of 20 to 60 years, the patient's knowledge of his diagnosis, the absence of known psychological and mental disorders other than cancer, obtaining a low level score Spiritual well being (20-40) and hope score less than 32 are willing to participate in the study consciously. The reluctance of the company, the criticality of the patient's clinical condition so that they are unable to attend the intervention sessions and the patient's death will be the exit from the study.
Intervention groups
The intervention group is a group that includes cancer patients undergoing chemotherapy for which spiritual care is provided.
Main outcome variables
Hope rate, Spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121208011692N2
Registration date:2018-03-07, 1396/12/16
Registration timing:registered_while_recruiting
Last update:2018-03-07, 1396/12/16
Update count:0
Registration date
2018-03-07, 1396/12/16
Registrant information
Name
Ardeshir Afrasiabifar
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 2223 4115
Email address
afrasiabifar.ardashir@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-15, 1396/10/25
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of spiritual care on the hope and spiritual well-being of cancer patients
Public title
Impact of spiritual care on the hope and spiritual well-being of cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of cancer by the oncologist
Chemotherapy treatment
Age range 20 to 60 years
Awareness of the patient's diagnosis
Not having known psychological and mental disorders other than cancer
Gaining a low level of spiritual health score (20-40) and a score of hope less than 32
Conscious willingness to participate in the study
Exclusion criteria:
Unwillingness to participate
Criticizing the patient's clinical condition in a way that is not able to attend intervention sessions.
Immigration from the study site
death
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
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
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی یاسوج
Street address
School of Nursing and Midwifery, Shahid Ghorbanali Jalil st.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591937770
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.YUMS.REC.1396.137
Health conditions studied
1
Description of health condition studied
Patients with cancer who referred to the chemo department of Yasuj Shahid Rajaei Hospital
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
hope rate
Timepoint
Before the intervention, one week after the intervention
Method of measurement
Schneider Hope Questionnaire
2
Description
spirituality health
Timepoint
Before the intervention, one week after the intervention
Method of measurement
Pulootzin and Ellison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention method of spiritual care based on the protocol of Bussing et al. (2010) in 4 main religious areas (Excellence), Being (meaning and purpose), emotional (relaxation) and social (communication) in 5 sessions, 2 hours before the onset of chemistry Therapy in the department will be performed by the performers. The duration of each session varied between 45 and 60 minutes.
Category
Behavior
2
Description
the control group, spiritual care is not taken and will only take the usual care of chemotherapy patients. If the results of the study were significant, in order to comply with the ethics, they will be provided with the necessary information through CDs and pamphlets.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj Shahid Rajaee Hospital
Full name of responsible person
Dr. Zahra Rezaei
Street address
Yasuj, Imam Hossein Square
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591837760
Phone
+98 74 2222 2292
Email
zahra.zarei@YUMS.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Maryoriad
Street address
Shahid motahari Blvd, yasuj University of Medical Science, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 6078 3334
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ardashir Afrasiabifar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid ghorbanali Jalil Ave, School of Nursing and Midwifery
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 2223 4541
Email
afrasiabifar@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ardashir Afrasiabifar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Ghorbanali Jalil st, School of Nursing and Midwifery
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 2223 5141
Email
afrasiabifar@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Asadolah Mosavi
Position
Non-faculty trainer
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Shahid Ghorbanali Jalil st, School of Nursing and Midwifery
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 2223 5141
Email
mosaviasadolah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the major outcomes of the data, including the amount of hope and spiritual well-being, will be shared.
When the data will become available and for how long
Data is available after the completion of the study in September 2019.
To whom data/document is available
Data will be available to researchers at universities and institutes.
Under which criteria data/document could be used
Data will be provided to the University of Medical Sciences if the University of Medical Sciences permits it, and merely using its results for further research.
What processes are involved for a request to access data/document
The applicant must submit a written request to the author of the article via email and the author will provide information to the applicants after obtaining permission from the Yasuj University Medical Sciences for a maximum of 7 days.