The effect of spiritual care on resilience and self-efficacy of elderly with cancer referred to oncology ward of shahid beheshti related hospitals
Design
Our study was a single-blind clinical trial in which the available samples were randomly divided into two control (25) and intervention (25) groups based on the inclusion and exclusion criteria. that the intervention group received spiritual care, derived from the spiritual-religious strategies of Richard and Bergin, and the control group did not receive any training.
Settings and conduct
The samples were selected in the oncology department of Shahada Tajrish and Imam Hossein (AS) hospitals in Tehran, and the intervention protocol included 6 sessions of 15 to 20 minutes of face-to-face training and the presentation of an educational booklet containing the topics presented in the training. And in this study, the blinding process was done on the study participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Seniors 60 years and older with a cancer diagnosis confirmed by a specialist doctor.
• Having complete alertness.
• Familiarity with Persian language.
Exclusion criteria:
• Having visual impairment.
• Having hearing impairment.
• Having an active mental illness.
• Treatment with sedatives (according to the patient herself).
Intervention groups
The spiritual care training intervention group will be derived from the spiritual-religious strategies of Richard and Bergin, which will be in-person training in 6 training sessions of 15-20 minutes and provide a training booklet containing the topics presented in the training sessions. And the control group will not receive any educational intervention.
Main outcome variables
Resilience, self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057845N1
Registration date:2023-10-13, 1402/07/21
Registration timing:prospective
Last update:2023-10-13, 1402/07/21
Update count:0
Registration date
2023-10-13, 1402/07/21
Registrant information
Name
Shiva Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7792 5821
Email address
shivabayat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care on resilience and self-efficacy of patients with cancer referred to oncology ward of shahid beheshti related hospitals
Public title
The effect of spiritual care on resilience and self-efficacy of patients with cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with cancer must be confirmed by a specialist doctor.
Having full consciousness
Getting to know the Persian language
Exclusion criteria:
Having visual impairment
Having hearing impairment
Having an active mental illness
Treatment with sedatives
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The initial sampling will be based on the available method and the main sampling of the present study will be in the form of block randomization. Patients who meet the inclusion criteria were randomly divided into two groups, the intervention group and the control group. Sealed Envelope Ltd 2019 online randomization service was used to generate the randomization list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 286, Rodbari St., Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1649848565
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.122
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Cancer
ICD-10 code
C17
ICD-10 code description
Malignant neoplasm of small intestine
3
Description of health condition studied
Cancer
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Resilience
Timepoint
2 and 4 weeks after the intervention
Method of measurement
Connor and Davidson Resilience Questionnaire (CD-RISC)
2
Description
Self-efficacy
Timepoint
2 and 4 weeks after the intervention
Method of measurement
General Self-Efficacy Scale (GSE-10)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention in the present study for the people of the intervention group will include providing spiritual care, derived from the spiritual-religious strategies of Richards and Bergin, who will receive 6 sessions in groups of 10 people 2 days a week (4 days apart) for 3 weeks. The duration of the intervention is 15-20 minutes, and the topics of spiritual care will be in the form of a face-to-face conversation and the presentation of a pamphlet containing the topics presented in the sessions. The sessions will include counseling, lectures, PowerPoint presentations, questions and answers, and group discussions, expressing experiences related to the topic and contents of the session between the researcher, patients, and their home caregivers. The phone and SMS system will be available to the participants during the study period to solve their questions and concerns. After the intervention, resilience and self-efficacy questionnaires will be completed by patients in both intervention and control groups.
Category
Lifestyle
2
Description
The group in which no intervention is used, so the level of resilience and self-efficacy of the participants will be evaluated at the beginning and three weeks later. Participants in this group will not receive any palliative care program. Like the participants in the intervention group, these patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs according to the doctor's request.
Tehran - Shahid Madani St. - Imam Hossein Medical Research Training Center
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behrouz Abtahi
Street address
Tehran - Shahid Chamran Highway, Yemen Street - Shahid Arabi Street, Next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Bayat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 286, Rodbari St., Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1649848565
Phone
+98 21 7792 5821
Email
shivabayat0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Bayat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 286, Rodbari St., Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1649848565
Phone
+98 21 7792 5821
Email
shivabayat0@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Bayat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 286, Rodbari St. Dardasht St. Narmak
City
Tehran
Province
Tehran
Postal code
1649848565
Phone
+98 21 7792 5821
Email
shivabayat0@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to demographic questionnaires and Connor and Davidson Resilience Questionnaire (CD-RISC) and General Self-Efficacy Scale (GSE-10) are presented as a summary, separately and in a file.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Clients, advisors, guides and all researchers
Under which criteria data/document could be used
General researchers are allowed to use any type of analysis.
From where data/document is obtainable
To receive documents, send to shivabayat0@gmail.com.
What processes are involved for a request to access data/document