The effect of spiritual care is determined based on Sound Heart Model on spirtual needs and spiritual Dryness of patients with cancer
Design
Sampling method available Sample size: 104 patient
Shift block randomization with a volume of four units in each block will be done.
Settings and conduct
This study is a randomized clinical trial. The study population includes all cancer patients (diagnosed by a doctor) undergoing treatment (chemotherapy, radiation therapy) who refer to Ayatollah Khansari Hospital in Arak in 1399.
Participants/Inclusion and exclusion criteria
Cancer patients
Inclusion criteria:
All patients with definitive diagnosis of cancer, access and ability to use social network by the patient, the patient's desire to participate in the study
Exclusion criteria:
Mental illness, inability to read and write (illiterate), lack of smart phone, age over 70 years
Intervention groups
Spiritual care Spiritual care based on Sound Heart Model in the intervention group is performed on three dependent variables: spiritual health, spiritual need, and spiritual Dryness through 2 months of virtual intervention. The control group receives routine care.
Main outcome variables
Spiritual needs
mental health
spiritual Dryness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201231049896N1
Registration date:2021-11-23, 1400/09/02
Registration timing:registered_while_recruiting
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
sobhan ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
sobhan.ebrahimpoor.110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spiritual care based on Sound Heart Model on spirtual needs and spiritual Dryness of patients with cancer
Public title
Effect of spiritual care on patients with cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are diagnosed with a definitive diagnosis of cancer
Patient access and the ability to use social network
The patient 's willingness to participate in the study
Exclusion criteria:
Mental illness
Inability to read and write (illiterate)
Lack of smart phone
Age over 70 years
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done when patients go to the hospital for chemotherapy. The samples will then be randomly divided into two groups of 52 with random allocation in block in intervention (A) and control (B) groups. First, the four blocks are defined as follows: ABAB, BBAA, BABA, BAAB, AABB, ABBA, etc., and individuals according to A and B will be divided into two groups of intervention and control. Patient A was in the supportive educational intervention group through Soroush virtual social network and patient B was in the control group.
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
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
City
tehran
Province
Tehran
Postal code
۳۳۵۱۸۵۶۶۳۹
Approval date
2021-04-28, 1400/02/08
Ethics committee reference number
IR.ARAKMU.REC.1400.012
Health conditions studied
1
Description of health condition studied
بیماران مبتلا به سرطان
ICD-10 code
D49
ICD-10 code description
Neoplasms of unspecified behavior
Primary outcomes
1
Description
Spiritual needs score in the Spiritual Needs Questionnaire (SpNQ)
Timepoint
Before the intervention, immediately after the intervention, one month after the end of the intervention
Method of measurement
Spiritual Needs Questionnaire (SpNQ)
2
Description
Spiritual Dryness score in the spiritual Dryness Scale (SDS)
Timepoint
Before the intervention, immediately after the intervention, one month after the end of the intervention
Method of measurement
Spiritual Dryness Scale (SDS)
3
Description
Spiritual health score in the spiritual health questionnaire
Timepoint
Before the intervention, immediately after the intervention, one month after the end of the intervention
Method of measurement
spiritual health of Palutzin and Ellison Questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Spiritual care intervention based on the model of sound heart, model of sound heart based on Islamic teachings is the paradigm of the Abrahamic religions that has been registered worldwide. The intervention is 8 virtual sessions over 2 months. Sequence of sessions including: 1. Familiarity and examination of the patient's feelings and attitude to the disease 2. Attention to the positive aspects of the disease on the axis of dualism, expressing the concept of divine testing 3. The effect of different dimensions of health on each other and spiritual self-awareness 4. Development of social relations 5 Exploitation of creation 6. Motivation and values 7. Development of relationship with God as a factor of creating hope, courage, optimism, endurance 8. Coping and adaptation. In addition to the above sessions, individuals receive a daily message and must send the word {read در to the researcher in a virtual application.
Category
Other
2
Description
Control group: They receive only routine hospital care (including training provided by physicians and nurses and hospital training pamphlets). Immediately after the intervention, participants in both groups complete three questionnaires again and are compared to evaluate the effectiveness of the educational and supportive intervention. One month after the end of the intervention, the questionnaires are completed again in order to follow up the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari tertiary referral hospital
Full name of responsible person
Sobhan Ebrahimpour
Street address
End of Daneshgah Street., Ayatollah Khansari Hospital., Arak
City
arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3336 7501
Email
www.pr_khansari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza kamali
Street address
Third Floor., Imam Musa Kazem Building., University Complex of the Great Prophet (PBUH)., Basij Square., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@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
Sobhan Ebrahimpour
Position
Master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
City
tehran
Province
Tehran
Postal code
3351856639
Phone
+98 21 6522 8400
Email
sobhan.ebrahimpoor.110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazi Nejat
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Third floor., School of Nursing Arak University of Medical Sciences., Sardasht,. Arak
City
arak
Province
Markazi
Postal code
3319693345
Phone
+98 86 3313 6055
Email
nazinejat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sobhan
Position
Master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
City
tehran
Province
Tehran
Postal code
3351856639
Phone
+98 21 6522 8400
Email
sobhan.ebrahimpoor.110@gmail.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
The use of data is allowed by mentioning the source.
From where data/document is obtainable
Nazi Nejat
Arak - Sardasht - Arak University of Medical Sciences
3319693345
nazinejat@gmail.com
sobhan ebrahimpour
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
3351856639
sobhan.ebrahimpoor.110@gmail.com
What processes are involved for a request to access data/document
The applicant must first register his / her request through the mentioned communication channels, and after reviewing the request for information, the information will be provided on condition of confidentiality and without identity information. This process will take a minimum of one month and a maximum of 2 months.