Main objectives of the plan:
Determine the impact of spiritual self-care education on perceived stress and caregiver burden among family caregivers of patients with blood cancers.
Sub-objectives of the plan:
Determine and compare perceived stress between the intervention and control groups before and after spiritual self-care education in family caregivers of patients with blood cancers.
Determine and compare caregiver burden between the intervention and control groups before and after spiritual self-care education in family caregivers of patients with blood cancers.
Design
The clinical trial has two groups, an intervention group and a control group, without blinding, randomisation of quadruple blocks, and randomisation was performed using the Random Allocation Software.
Settings and conduct
The study recruits caregivers of hematologic cancer patients from Tehran's Valiasr Hospital. Participants are randomized in blocks of four with concealed allocation. Both groups complete the questionnaires; the intervention group receives six online spiritual care sessions with assignments and feedback, while the control group receives standard nursing care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18–65 years
Primary caregiver of a patient with hematologic cancer with a confirmed diagnosis, within two months after chemotherapy
Ability to read and write in Persian
Willingness to participate in the study and sign informed consent
Exclusion criteria:
Participation in other psychological or spiritual intervention programs
History of diagnosed psychiatric disorders
Intervention groups
The intervention group receives spiritual care training through online sessions. The control group receives routine nursing care and, after the sessions, also receives an educational video.
Main outcome variables
perceived stress; caregiver burden.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251022067729N1
Registration date:2026-05-18, 1405/02/28
Registration timing:prospective
Last update:2026-05-18, 1405/02/28
Update count:0
Registration date
2026-05-18, 1405/02/28
Registrant information
Name
Zahra Kafshgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 6310
Email address
zahrakafshgar.edu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Spiritual Self-Care Training on Perceived Stress and care burden in Family Caregivers of Patients with blood cancers
Public title
Investigating the Effect of Spiritual Self-Care Training in Family Caregivers of Patients with blood cancers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 65-18 years
The main caregiver of a patient with blood cancers with a definite diagnosis and two months after chemotherapy
Ability to read and write in Persian
Willingness to participate in the study and sign the informed consent
Exclusion criteria:
Participation in other psychological or spiritual intervention programs
History of diagnosed psychiatric disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
First, the samples are included in the study after checking the criteria for entering the available sampling method. Then randomization is done in blocks of four in two control and test groups, RAS (Random Allocation Software) is used for randomization and the results are placed in sealed envelopes to hide the random allocation.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Ghods Street, Central Headquarters of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14176-13151
Approval date
2025-12-30, 1404/10/09
Ethics committee reference number
IR.TUMS.FNM.REC.1404.237
Health conditions studied
1
Description of health condition studied
Family Caregivers of Patients with blood cancers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perceived Stress in the Cohen Questionnaire
Timepoint
Perceived stress scores at the beginning of the study (before the intervention started) and one week after the end of the training sessions.
Method of measurement
Cohen's Perceived Stress Questionnaire
2
Description
Caregiver Burden in the Zarit scale
Timepoint
Caregiver Burden scores at the beginning of the study (before the intervention started) and one week after the end of the training sessions.
Method of measurement
Zarit caregiver burden scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Recipients of six online spiritual self-care training sessions, each session lasting 60 minutes, delivered over three weeks (two sessions per week) by a trained spiritual care provider. Session descriptions: First: Introduction to spirituality in the family. Second: Meaning in suffering and the role of the family. Third: Hope and resilience. Fourth: Forgiveness and freedom from guilt. Fifth: Connection and mutual support. Sixth: Summary and self-care. At the end of each session, participants will be given a task to complete, and at the beginning of each session, feedback will be gathered on the previous session's task and content. At the end of all the sessions, participants will receive a file containing the training sessions.
Category
Other
2
Description
Control group: They are receiving routine medical care. At the end of the study, they will be provided with a file of the training sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Zahra Panahi
Street address
End of Keshavarz Boulevard, Imam Khomeini Hospital Complex, Valiasr Hospital