Protocol summary

Study aim
Determining the effect of a spiritual care program on resilience and death anxiety in parents of children and adolescents with progressive and life-threatening diseases
Design
Intervention
Settings and conduct
Ekbatan Hospital affiliated to Hamadan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Having a child with a progressive and life-threatening illness according to medical records, Not having mental diseases, Willingness to participate in the study
Intervention groups
Intervention group: Participants in the intervention group will receive spiritual care training in five sessions for 5 weeks (one session per week) and each session will last 90 minutes. The training contents include: the first session (orientation, assessment and recognition), the second session (supportive presence), the third session (support of religious rituals), the fourth session (use of support systems) and the fifth session (evaluation of the spiritual care program).
Main outcome variables
Resilience and Parental death anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190703044082N11
Registration date: 2024-12-15, 1403/09/25
Registration timing: retrospective

Last update: 2024-12-15, 1403/09/25
Update count: 0
Registration date
2024-12-15, 1403/09/25
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-15, 1403/06/25
Expected recruitment end date
2024-11-27, 1403/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a spiritual care program on resilience and death anxiety in parents of children and adolescents with progressive and life-threatening diseases
Public title
Investigating the effect of a spiritual care program on resilience and death anxiety in parents of children and adolescents with progressive and life-threatening diseases
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with a progressive and life-threatening illness according to medical records Not having mental diseases Willingness to participate in the study
Exclusion criteria:
Having a chronic, non-life-threatening illness based on medical records
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
N/A
Randomization description
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
Research ethics committee of Hamadan University of Medical Sciences
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6817838698
Approval date
2024-09-14, 1403/06/24
Ethics committee reference number
IR.UMSHA.REC.1403.395

Health conditions studied

1

Description of health condition studied
leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia

2

Description of health condition studied
Bone tumor
ICD-10 code
C7B.03
ICD-10 code description
Secondary carcinoid tumors of bone

Primary outcomes

1

Description
Resilience
Timepoint
Before and after the intervention
Method of measurement
Davidson-Connor Resilience Questionnaire

2

Description
Death anxiety
Timepoint
Before and after the intervention
Method of measurement
Templar’s Death Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive spiritual care training in five sessions for 5 weeks (one session per week) and each session will last 90 minutes. The training contents include: the first session (orientation, assessment and recognition), the second session (supportive presence), the third session (support of religious rituals), the fourth session (use of support systems) and the fifth session (evaluation of the spiritual care program).
Category
Rehabilitation

2

Description
Control group: The Participants received routine care
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital affiliated to Hamadan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
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
Fateme Mohammadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Fax
Email
mohammadifateme47@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.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
Not applicable
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
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