The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception, Hope, Quality of life, Anxiety and depression among Children with Cancer
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Protocol summary
The objective was to determine the effect of Cognitive-Behavioral Art-Play Therapy and Cognitive-Behavioral Story Therapy on pain perception and hope among Children with cancer.
The objective was to determine the effect of Cognitive-Behavioral Art-Play Therapy and Cognitive-Behavioral Story Therapy on pain perception, hope, quality of life, anxiety and depression among Children with cancer.
The objective was to determine the effect of Cognitive-Behavioral Art-Play Therapy and Cognitive-Behavioral Story Therapy on pain perception, hope, quality of life, anxiety and hopedepression among Children with cancer.
این پژوهش با هدف تعیین تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد و امیدواری کودکان مبتلا به سرطان اجرا می شود.
این پژوهش با هدف تعیین تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد، امیدواری، کیفیت زندگی، اضطراب و افسردگی کودکان مبتلا به سرطان اجرا می شود.
این پژوهش با هدف تعیین تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد، امیدواری، کیفیت زندگی، اضطراب و امیدواریافسردگی کودکان مبتلا به سرطان اجرا می شود.
pain perception and hope.
pain perception, hope, quality of life, anxiety and depression
pain perception, hope, quality of life, anxiety and hope.depression
ادراک درد و امیدواری.
ادراک درد، امیدواری، کیفیت زندگی، اضطراب و افسردگی
ادراک درد، امیدواری، کیفیت زندگی، اضطراب و امیدواری.افسردگی
General information
The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception and Hope among Children with Cancer
The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception, Hope, Quality of life, Anxiety and depression among Children with Cancer
The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception, Hope, Quality of life, Anxiety and Hopedepression among Children with Cancer
تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد و امیدواری در کودکان مبتلا به سرطان
تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد، امیدواری، کیفیت زندگی، اضطراب و افسردگی در کودکان مبتلا به سرطان
تأثیر هنر ـ بازی درمانی شناختی ـ رفتاری و قصه درمانی شناختی ـ رفتاری بر ادراک درد، امیدواری، کیفیت زندگی، اضطراب و امیدواریافسردگی در کودکان مبتلا به سرطان
Health conditions studied
#1
empty
quality of life
quality of life
empty
کیفیت زندگی
کیفیت زندگی
#2
empty
F41.9
F41.9
empty
Anxiety disorder, unspecified
Anxiety disorder, unspecified
empty
anxiety
anxiety
empty
اضطراب
اضطراب
#3
empty
F38.1
F38.1
empty
Other recurrent mood [affective] disorders
Other recurrent mood [affective] disorders
empty
depression
depression
empty
افسردگی
افسردگی
Primary outcomes
#1
empty
Quality of life - The range of test scores between 0 to 100 and the higher scores
Quality of life - The range of test scores between 0 to 100 and the higher scores
empty
کیفیت زندگی ـ طیف نمرات بین صفر تا 100 و نمرات بالاتر بیانگر کیفیت زندگی بیشتر فرد پاسخگو
کیفیت زندگی ـ طیف نمرات بین صفر تا 100 و نمرات بالاتر بیانگر کیفیت زندگی بیشتر فرد پاسخگو
empty
Measurment of pre-test quality of life (pre-test) and post test(post-test)
Measurment of pre-test quality of life (pre-test) and post test(post-test)
empty
اندازه گیری کیفیت زندگی قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
اندازه گیری کیفیت زندگی قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
empty
Child quality of life scale(kid-KINDL)
Child quality of life scale(kid-KINDL)
empty
پرسشنامه کیفیت زندگی کودکان(kid-KINDL)
پرسشنامه کیفیت زندگی کودکان(kid-KINDL)
#2
empty
Anxiety - The range of test scores between 0 to 114 and the higher scores
Anxiety - The range of test scores between 0 to 114 and the higher scores
empty
اضطراب ـ طیف نمرات بین صفر تا 114 و نمرات بالاتر بیانگر اضطراب بیشتر فرد پاسخگو
اضطراب ـ طیف نمرات بین صفر تا 114 و نمرات بالاتر بیانگر اضطراب بیشتر فرد پاسخگو
empty
Measurment of pre-test anxiety (pre-test) and post test(post-test)
Measurment of pre-test anxiety (pre-test) and post test(post-test)
empty
اندازه گیری اضطراب قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
اندازه گیری اضطراب قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
empty
Spence children anxiety scale
Spence children anxiety scale
empty
مقیاس اضطراب کودکان اسپنس
مقیاس اضطراب کودکان اسپنس
#3
empty
Depression - the smallest average used for diagnose non-depressed children is 60. so subjects with a score of 84 and above are known to be depressed.
Depression - the smallest average used for diagnose non-depressed children is 60. so subjects with a score of 84 and above are known to be depressed.
empty
افسردگی ـ کوچکترین میانگین 60 برای تشخیص کودکان غیر افسرده مورد استفاده قرار گرفته می شود. بنابراین، آزمودنی هایی که نمره آنها 84 و بالاتر باشد به عنوان افسرده شناخته می شوند.
افسردگی ـ کوچکترین میانگین 60 برای تشخیص کودکان غیر افسرده مورد استفاده قرار گرفته می شود. بنابراین، آزمودنی هایی که نمره آنها 84 و بالاتر باشد به عنوان افسرده شناخته می شوند.
empty
Measurment of pre-test depression (pre-test) and post test(post-test)
Measurment of pre-test depression (pre-test) and post test(post-test)
empty
اندازه گیری افسردگی قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
اندازه گیری افسردگی قبل از مطالعه(پیش آزمون) و پس از مطالعه(پس آزمون)
empty
Child depression scale - abbreviated
Child depression scale - abbreviated
empty
فرم کوتاه پرسشنامه افسردگی کودکان
فرم کوتاه پرسشنامه افسردگی کودکان
Protocol summary
Study aim
The objective was to determine the effect of Cognitive-Behavioral Art-Play Therapy and Cognitive-Behavioral Story Therapy on pain perception, hope, quality of life, anxiety and depression among Children with cancer.
Design
Semi-experimental method and three-group research design, including a group of Cognitive-Behavioral Art-Play Therapy , an Cognitive-Behavioral Story Therapy group and a control group with two stages of pre-test and post-test. A statistical population of 75 Children with Cancer in Shiraz city who were admitted to Amir Hospital in 1397. Of these, 45 people are selected through targeted sampling.
Settings and conduct
Children with cancer who were hospitalized at Amir Hospital in Shiraz City.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Conscious consent to participation in research, Age Range 8 to 12 years, No drug used to reduce anxiety and depression, No other physical and mental illness, In the life of the parents and the lives of both parents with the child, Cancer children are undergoing chemotherapy or have completed the course of chemotherapy, Both sexes.
Exclusion Criteria: Unwillingness to attend or refuse to continue working, Sick children who are not able to attend in meetings, Children staying in hospital for less than a week.
Intervention groups
The group of Cognitive-Behavioral Art-Play Therapy was grouped in 12 sessions of 60 to 90 minutes and the Cognitive-Behavioral Story Therapy group was treated as two sessions a week for 12 sessions of 90 minutes. The control group does not receive any treatment during this period.
Main outcome variables
pain perception, hope, quality of life, anxiety and depression
General information
Reason for update
Acronym
خالی
IRCT registration information
IRCT registration number:IRCT20181117041680N1
Registration date:2018-11-28, 1397/09/07
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:1
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
Zohreh Shojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 4673
Email address
zohreh.shojaei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2018-06-20, 1397/03/30
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2018-10-22, 1397/07/30
Scientific title
The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception, Hope, Quality of life, Anxiety and depression among Children with Cancer
Public title
Children with Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
-Conscious consent to participation in research (by parent and child)
-Age Range 8 to 12 years(children of primary school age)
-No drug used to reduce anxiety and depression
-No other physical and mental illness
-In the life of the parents and the lives of both parents with the child
-Cancer children are undergoing chemotherapy or have completed the course of chemotherapy
-Both sexes(girl and boy).
Exclusion criteria:
-Unwillingness to attend or refuse to continue working
-Sick children who are not able to attend in meetings
-Children staying in hospital for less than a week
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The sample Children are selected purposefully, will be assigned to one of the three groups of Art-Play Therapy, Story Therapy, and Control or Testimonial in a random manner(lottery).(Random Assignment).
Blinding (investigator's opinion)
Single blinded
Blinding description
The experimental group, the group of Cognitive-Behavioral Art-Play Therapy, was grouped in 12 sessions of 60 to 90 minutes and the Cognitive-Behavioral Story Therapy Group was treated as a weekly two session for 12 sessions of 90 minutes.The control group will not receive any treatment during this period. In the present study, the results of research implementation with identifiable code are available only to the researcher for the data analyzer and the safety committee and data monitoring. Therefore, these individuals will not be aware of what information is collected about which group and variables. Participants will also not get any information about which variables are being used and how they are clearly and precisely determined by which type of treatment they use from the two treatments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Reseaches of Isfahan Azad University (Khorasgan)
Street address
university Blvd- Arghavaniyeh- East Jey- Esfahan
City
esfahan
Province
Isfehan
Postal code
81551-29998
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.022
Health conditions studied
1
Description of health condition studied
children with cancer
ICD-10 code
C79.9
ICD-10 code description
Secondary malignant neoplasm of unspecified site
2
Description of health condition studied
Pain Perception
ICD-10 code
R30.9
ICD-10 code description
Painful micturition, unspecified
3
Description of health condition studied
hope
ICD-10 code
ICD-10 code description
4
Description of health condition studied
quality of life
ICD-10 code
ICD-10 code description
5
Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
6
Description of health condition studied
depression
ICD-10 code
F38.1
ICD-10 code description
Other recurrent mood [affective] disorders
Primary outcomes
1
Description
Pain perception-The range of test scores between 0 to 10 and the higher scores represent the greater pain perception of the accountable person.
Timepoint
Measurment of pre-test pain perception(pre-test) and post test(post-test)
Method of measurement
Oucher Scale
2
Description
Hope -The range of test scores between 6 to 36 and the higher scores represent the greater hope of the accountable person.
Timepoint
Measurment of pre-test hope (pre-test) and post test(post-test)
Method of measurement
Children and adolescent's hope scale
3
Description
Quality of life - The range of test scores between 0 to 100 and the higher scores
Timepoint
Measurment of pre-test quality of life (pre-test) and post test(post-test)
Method of measurement
Child quality of life scale(kid-KINDL)
4
Description
Anxiety - The range of test scores between 0 to 114 and the higher scores
Timepoint
Measurment of pre-test anxiety (pre-test) and post test(post-test)
Method of measurement
Spence children anxiety scale
5
Description
Depression - the smallest average used for diagnose non-depressed children is 60. so subjects with a score of 84 and above are known to be depressed.
Timepoint
Measurment of pre-test depression (pre-test) and post test(post-test)
Method of measurement
Child depression scale - abbreviated
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: The Cognitive-Behavioral Art-Play Therapy Group of 15 patients randomly assigned to this group are treated for 12 sessions at 90 minutes for two months.
Category
Behavior
2
Description
Second intervention group: The group of Cognitive-Behavioral Story Therapy, which was randomly assigned to 15 individuals randomly assigned to this group, was treated for 12 sessions at 90 minutes for two months.
Category
Behavior
3
Description
Control group: This group of 15 randomly selected individuals in this group will receive no treatment for two months. At the same time, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Cognitive-Behavioral Art-Play Therapy or Cognitive-Behavioral Story Therapy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Medical Oncology Hospital
Full name of responsible person
Mohammad Reza Bordbar
Street address
Amir Medical Oncology Hospital, 11 Station, Culture City, Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3632 3731
Fax
+98 71 3632 5655
Email
amirhp@sums.ac.ir
Web page address
http://amirhosp.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Golparvar
Street address
Arghavanieh, Jey St., Esfahan, Iran. Post Code : 81551-39998. P.O.BOX:81595-158
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
mgolparvar@khuisf.ac.ir
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
Private
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
Zohreh Shojaei
Position
PhD Student of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Educational Sciences, Islamic Azad University, Isfahan (Khorasgan)
City
Esfahan
Province
Isfehan
Postal code
81551-29998
Phone
+98 31353540019
Email
zohreh_shojaei100@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Golparvar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Educational Sciences, Islamic Azad University, Isfahan (Khorasgan)
City
Esfahan
Province
Isfehan
Postal code
81551-29998
Phone
+98 31353540019
Email
mgolparvar@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Shojaei
Position
PhD Student of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology , Faculty of Psychology and Educational Sciences, Islamic Azad University, Isfahan (Khorasgan) Branch, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
81551-29998
Phone
+98 31353540019
Email
zohreh_shojaei100@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
ethical commitment to participants
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only the statistical analysis results can be shared in the form of an approved scientific article.
When the data will become available and for how long
The beginning of the access period is in late 1397.
To whom data/document is available
According to the subject, the data will only be available to other academic researchers in case of necessity for meta-analysis studies.
Under which criteria data/document could be used
Only in the form of scientific paper approved by the professors of the field studied.
From where data/document is obtainable
Mohsen golparvar and zohreh shojaei
mgolparvar@khuisf.ac.ir
zohreh_shojaei100@yahoo.com
What processes are involved for a request to access data/document