Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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Children with cancer who were hospitalized at Amir Hospital in Shiraz City.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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pain perception, hope, quality of life, anxiety and depression
General information
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Reason for update
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Acronym
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خالی
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IRCT registration information
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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
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Registration date
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2018-11-28, 1397/09/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-20, 1397/03/30
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Expected recruitment end date
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2018-10-22, 1397/07/30
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Actual recruitment start date
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2018-06-20, 1397/03/30
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Actual recruitment end date
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2018-10-22, 1397/07/30
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Trial completion date
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2018-10-22, 1397/07/30
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Scientific title
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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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Public title
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Children with Cancer
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
45
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-03, 1397/03/13
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1397.022
Health conditions studied
1
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Description of health condition studied
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children with cancer
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ICD-10 code
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C79.9
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ICD-10 code description
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Secondary malignant neoplasm of unspecified site
2
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Description of health condition studied
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Pain Perception
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ICD-10 code
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R30.9
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ICD-10 code description
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Painful micturition, unspecified
3
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Description of health condition studied
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hope
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ICD-10 code
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ICD-10 code description
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4
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Description of health condition studied
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quality of life
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ICD-10 code
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ICD-10 code description
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5
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Description of health condition studied
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anxiety
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ICD-10 code
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F41.9
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ICD-10 code description
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Anxiety disorder, unspecified
6
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Description of health condition studied
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depression
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ICD-10 code
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F38.1
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ICD-10 code description
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Other recurrent mood [affective] disorders
Primary outcomes
1
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Description
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Pain perception-The range of test scores between 0 to 10 and the higher scores represent the greater pain perception of the accountable person.
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Timepoint
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Measurment of pre-test pain perception(pre-test) and post test(post-test)
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Method of measurement
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Oucher Scale
2
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Description
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Hope -The range of test scores between 6 to 36 and the higher scores represent the greater hope of the accountable person.
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Timepoint
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Measurment of pre-test hope (pre-test) and post test(post-test)
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Method of measurement
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Children and adolescent's hope scale
3
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Description
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Quality of life - The range of test scores between 0 to 100 and the higher scores
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Timepoint
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Measurment of pre-test quality of life (pre-test) and post test(post-test)
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Method of measurement
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Child quality of life scale(kid-KINDL)
4
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Description
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Anxiety - The range of test scores between 0 to 114 and the higher scores
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Timepoint
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Measurment of pre-test anxiety (pre-test) and post test(post-test)
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Method of measurement
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Spence children anxiety scale
5
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Description
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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.
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Timepoint
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Measurment of pre-test depression (pre-test) and post test(post-test)
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Method of measurement
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Child depression scale - abbreviated
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
3
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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ethical commitment to participants
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Only the statistical analysis results can be shared in the form of an approved scientific article.
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When the data will become available and for how long
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The beginning of the access period is in late 1397.
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To whom data/document is available
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According to the subject, the data will only be available to other academic researchers in case of necessity for meta-analysis studies.
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Under which criteria data/document could be used
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Only in the form of scientific paper approved by the professors of the field studied.
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From where data/document is obtainable
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Mohsen golparvar and zohreh shojaei
mgolparvar@khuisf.ac.ir
zohreh_shojaei100@yahoo.com
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What processes are involved for a request to access data/document
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Apply to Mohsen Golparvar and zohreh shojaei
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Comments
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