This study is a randomized clinical trial with a design of two pre-test and post-test groups aimed at determining the effect of the spiritual support on the caregiver's stress and the quality of life in children aged 8 to 12 suffering from Leukemia hospitalized in Oncology ward of Dr. Sheikh hospital. The studied population consists of the children aged 8 to 12 suffering from acute Lymphoblastic Leukemia hospitalized in Mashhad Dr Sheikh hospital and their caregivers.
Inclusion criteria: Having informed written consents, Having Iranian citizenship, Residing in Mashhad and the surrounding areas, Having literacy, Not suffering from known mental illnesses, A confirmed diagnosis of Acute lymphoblastic leukemia by doctor.
Exclusion criteria: The unwillingness of the individual to participate in the study, Occurrence of an emergency interfering situation in the continuation of the project, Receiving a comprehensive educational program. Sample size was considered 30 persons in each group and all together about 60 persons. In this study, intervention is 5 sessions enjoying spiritual support given by an investigator and supervised by a religious expert. Instructions will be through speeches, asking and answering questions, group discussions and distribution of the printed version of the materials presented in each session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052425713N1
Registration date:2016-08-08, 1395/05/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-08, 1395/05/18
Registrant information
Name
Elham Zafarian
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3341 4883
Email address
zafarianme921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual Support on caregiver's stress and quality of life of children aged 8 to12 with leukemia
Public title
The Effect of Spirituality on caregiver's stress and quality of life of children with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having informed written consents, Having Iranian citizenship, Residing in Mashhad and the surrounding areas, Having literacy, Not suffering from known mental illnesses, A confirmed diagnosis of Acute lymphoblastic leukemia by doctor.
Exclusion criteria: The unwillingness of the individual to participate in the study, Occurrence of an emergency interfering situation in the continuation of the project, Receiving a comprehensive educational program.
Age
From 8 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
By randomized table
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for research, Ghoraishy Building, University St, Mashhad
City
Mashhad
Postal code
91375345
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.MUMS.REC.1395.74
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
D72.8
ICD-10 code description
Other specified disorders of white blood cells
Primary outcomes
1
Description
Caregiver's stress
Timepoint
Before and after the intervention
Method of measurement
DASS questionnaire
Secondary outcomes
1
Description
Quality of life of children
Timepoint
Before and 1 month after the intervention
Method of measurement
Teenagers'quality of life questionnaire
Intervention groups
1
Description
No intervention is made for control group
Category
N/A
2
Description
Intervention group: will participate in 5 sessions of sixty minutes each day based on Richards and Bergin pattern focusing on the Islamic rituals and including psycho-spiritual components such as: prayer, trust and appeal, patience, gratitude and forgiveness. In the first session, participants will be asked to put forward their supportive needs in terms of personal experience. During the second session caregivers will be familiar with the role of trust and appeal in getting along with psychological stress caused by child disease and will be trained to know the theoretical bases of trust and appeal, trust as a contrastive strategy to deal with stress, ways to achieve the trust and appeal and How one can use trust and appeal as effective contrastive strategy to convert inappropriate negative excitements to negative excitements. In the third session the role of prayer in solving their problems and the impact of prayer on the process of problem solving is discussed. Also some instructions will be given about the value and importance of prayer, its philosophy, familiarity with the correct practical way of praying, And familiarity with the effects of prayer on the relationship of the individual with God, oneself and others. In the fourth session they will be familiar with the concept of thanksgiving and its effect on reducing negative excitements and effective beliefs will be taught about thanksgiving´s effect to decrease caregivers ´negative excitements and in the last session they will be familiar with the steps of patience and they will be taught about the value of patience, kinds of patience, steps of patience and patience as a strategy to deal with the pressures caused by the child´s illness.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Sheikh hospital
Full name of responsible person
Hava Abdollahi
Street address
Taheri St,Tohid Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for research, Ghoraishy Building, University St, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Zafarian
Position
Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Iran
Phone
+98 51 3341 4883
Fax
Email
zafarianme921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
HamidReza Behnam Vashani
Position
Faculty of Nursing and Midwifery, master in nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ebne Sina St, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
BehnamHR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Zafarian
Position
Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Iran
Phone
+98 51 3341 4883
Fax
Email
zafarianme921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)