Determining the effect of spiritual care based on Ghalbe Salim on the anxiety and self-esteem in children with cancer
Design
40 children with cancer were selected randomly and divided into two intervention and control groups and each participant was assigned a code.
Settings and conduct
In this study, while explaining the research objectives to 40 children with cancer under the treatment of Dr. Sheikh Mashhad Educational and Medical Center, March children's anxiety questionnaire and Cooper Smith's self-esteem were given to two control and intervention groups. Spiritual care sessions for the intervention group were performed in 5 sessions of 60-45 minutes. The control group received only routine training during reception and hospitalization, and after 5 sessions, both groups were reexamined.
Participants/Inclusion and exclusion criteria
The criteria for entering this study was the ability to have a suitable communication with the researcher, willing to participate in research, physical and mental preparation, at least ability to read and write, able to speak in Persian, be Muslim and have a Shiite religion. Participants who did not wish to continue the study, those with mental disorders such as depression, anxiety, and those who missed more than one session were excluded from the study.
Intervention groups
Intervention group: spiritual care training in the form of 5 face-to-face sessions. Each session is presented for 60-45 minutes. The control group is not given any training.
There were no meetings for the control group. They received only routine hospital training, including several pamphlets containing brief information on disease and care in chemotherapy.
Main outcome variables
Level of anxiety and self-esteem ; Ability to spiritual care based on Ghalbe Salim ; Child care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170512033932N9
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Hosein Motahariniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4908
Email address
h_hojjati@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
2018-05-06, 1397/02/16
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
The Effect of Spiritual Care Based on Ghalbe Salim on Anxiety and Self-Esteem in children with Cancer
Public title
The Effect of Spiritual Care Based on Ghalbe Salim in children with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to have a suitable communication with the researcher during the initial interview.
Be willing to participate in research and be able to tolerate meetings.
Have the necessary physical and mental preparation to answer the questions.
Have at leastability to read and write
Be able to speak in Persian.
Be a Muslim and have a Shiite religion
Exclusion criteria:
Suffering from mental disorders such as depression and anxiety
Age
From 7 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested
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 for Biological Researches at the Azad University of Shahrood
Street address
Azad University Ave,Shahrood Azad University
City
Shahrood
Province
Semnan
Postal code
43189-36199
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.003
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
Self Esteem Score by Cooper Smith Self-Esteem Questionnaire
Timepoint
Before the intervention begins and after intervention
Method of measurement
Based on total self-esteem score
2
Description
En Anxiety Scale from Marx's Anxiety Inventory
Timepoint
Before the intervention begins and after intervention
Method of measurement
Based on total score of anxiety
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group in this study is training on spiritual care and focusing on the religion of Islam for patients in five sessions (45-60 minutes per session), which are described below: session 1: Introduce and familiarize members with each other, learn about the reasons for forming a group and get acquainted with the rules of the group such as confidentiality, respect each other's opinions and tolerance of different views, number and time of meetings and the need for continuous attendance until the end of treatment. Session 2: The role of trust and recourse coping with stress caused by a child's illness. Familiarity with the theoretical foundations of recourse, stages and effects of recourse, the concept of recourse, familiarity with shrines, familiarity with the books of pilgrimage, the role of recourse in coping with stress, recourse against stress, familiarity with psychological pressure, recourse against stress, the effect of recourse on life pressure control or effective skills in recourse. Session 3: The role of prayer and supplication in solving problems and familiarity with the effect of prayer on one's relationship with God, oneself and others. Session 4: gratitude and its effect on reducing the negative emotions and teaching the effective beliefs in the effect of gratitude to reduce negative emotions. Session 5: steps of patience and training on the value of patience, patience and effective beliefs in patience, existence of a merciful God, the effect of patience on changing thoughts, patience as an effective strategy in coping with childhood illness.
Category
Behavior
2
Description
There were no meetings for the control group. They received only routine hospital training, including several pamphlets containing brief information on disease.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaikh Mashhad Learning Pediatric Center
Full name of responsible person
Hamid Farhangi
Street address
St. Sa'id Qarani Ave Dr. Sheikh
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3801 2469
Fax
+98 51 3801 2469
Email
mozhde.vd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruholah Samie
Street address
Azad Univercity Blvd, Azad Univercity
City
Aliabad Katun
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Fax
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mozhde Vazifedust
Position
MSC Student of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad University, Azad Blvd.
City
Aliabad Katul
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
mozhde.vd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mozhde Vazifedust
Position
MSC Student of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad Ave, Azad Univercity
City
Aliabad Katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
mozhde.vd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojjati
Position
Associate Professor Of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Azad Blvd.
City
Aliabad Katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1392@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
Undecided - It is not yet known if there will be a plan to make this available
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