Protocol summary

Study aim
Due to the lack of suitable infrastructures for appropriate entertainments of adolescents in medical settings, and the high cost of infrastructure preparation in these centers, new methods are needed to control the symptoms of fatigue and anxiety as common side effects of treatment in adolescents. The results of this study may introduce an effective, innovative, and cost-effective method through the wider use of board games to control these symptoms.
Design
Controlled clinical trial - parallel groups - without blinding - randomized - on 66 patients
Settings and conduct
Due to the existence of two separate oncology wards in Mahak Center (Tehran city), one ward will be randomly assigned to the control group and the other to the intervention group. Routine medication and pamphlets in the Mahak will be considered as the routine intervention for both groups. Patients in the intervention group will be divided into groups of 4-6 people and a training session will be held to teach how to play games. In the intervention group, the researcher will play board games for 4 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria :having the experience of at least one course of chemotherapy, and clear evidence of cancer diagnosis based on the medical record and treatment hospitalization. exclusion criteria :mental illness based on the adolescent's medical record.
Intervention groups
Routine medication and pamphlets in the Mahak will be considered as the routine intervention groups. The people in the intervention group will be divided into groups of 6 people and a training session will be held to teach them how to play games. In the intervention group, the researcher will play board games 75 minutes per day for 4 days including mafia and chicken milk games in the game room. The researcher will have the role of the facilitator in games.
Main outcome variables
Anxiety Fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210101049901N1
Registration date: 2021-04-07, 1400/01/18
Registration timing: retrospective

Last update: 2021-04-07, 1400/01/18
Update count: 0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
fatemeh derakhshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 7520
Email address
kosar1171@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of board games on anxiety and fatigue of adolescents with leukemia
Public title
The effect of board games on cancer anxiety and fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Experience at least 1 course of chemotherapy Diagnosis of cancer based on medical records Adolescent hospitalization for treatment
Exclusion criteria:
Mental illness based on adolescent medical records
Age
From 11 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the existence of two separate wards in Mahak Medical Center to prevent the dissemination of information between the two groups, one ward will be randomly assigned to the control group and the other to the intervention group. To do so, wards numbers will be written on two separate balls and will be placed inside a bag. The control group is assigned to the first piked ball and while the remaining ball represents the intervention group. The researcher will play in groups with 4-6 persons which are subbranches of the intervention group. It should be noted that these two wards are not distinguished in terms of hospitalizing physicians, physical space, and type of patients. patients will be randomly allocated to the control or intervention group with the help of 4 block randomization created with SPSS during the admission. To do so, the hospital admission will contact the researcher during patient reception to determine the patient ward based on the prepared SPSS list. To prepare the SPSS list, first in the "variable" section, a variable named ID is created, then the "compute variable" is chosen in the "transform" toolbar. In the "Compute variable" window, "ALL" is chosen for the "function group" and "Casenum" for the "function and special variables". Next, the "A" varialble is created based on the 0.1+(casenum/4)-0.49 formula. The "A" parameter is Rounded by choosing the "Rnd(1)" option in the "function and special variables" sub-window to create the "B" parameter. In the next step, a "random number" with a "uniform" distribution between 0-1 is created. After that, "the Rank case" is chosen in the "transform" toolbar, and the "uniform" variable is ranked based on the "B" variable. As a result, in the created variable, numbers 1.0 and 2.0 represent the control group, and 3.0 and 4.0 represent the intervention.
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 Arak University of Medical Sciences
Street address
Shahid Zainuddin - Zulfiqar 1, No. 18
City
Qom
Province
Ghoum
Postal code
3713197773
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.ARAKMU.REC.1399.269

Health conditions studied

1

Description of health condition studied
Fatigue and anxiety in adolescents with leukemia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue mark based on the "cancer related fatigue" questionnaire
Timepoint
Before and after intervention
Method of measurement
Iranian Version of Cancer-Related Fatigue questionnaire

2

Description
Anxiety marks based on Hospital Anxiety and Depression Scale (HADS)
Timepoint
Before and after intervention
Method of measurement
Anxiety section in the Hospital Anxiety and Depression Scale (HADS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: adolescents in the intervention group will be divided into groups of 4-6 people. A training session will be held to teach them how to play the games. In the intervention group, the researcher will play board games 75 minutes per day for 4 days (1 game every 2 days) including mafia and "chicken milk" in the game room. The researcher will play the role of facilitator in the playing games. In the "chicken milk" game, the players should define a product with the help of cards they receive. Then, they have to present their product to other players and persuade them to buy it. Mafia game is an interactive game based on the discussion between players. The players will be categorized into two groups of mafias and civilians by the cards they receive randomly. The civilians should identify mafia group members by cooperating with each other. At the beginning of the study, pre-tests will be taken from both groups based on questionnaires. After 4 days, post-tests will be taken from both groups with questionnaires.
Category
Treatment - Other

2

Description
Control group: medicine and existing pamphlets in the Mahak Hospital will be considered as routine care in both groups.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahak hospital
Full name of responsible person
Fatemeh Derakhshan
Street address
Mahak Hospital
City
Tehran
Province
Tehran
Postal code
۱۹۵۶۹۹۳۴۶۱
Phone
+98 21 2350 1000
Email
pr@mahak-charity.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Sajadi
Street address
Arak University of Medical Science
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3501
Email
amozesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Derakshan
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qom - Zeindodin - Zolfaghar 1` N 18
City
Qom
Province
Ghoum
Postal code
3713197773
Phone
32707520
Email
kosar1171@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Derakshan
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zeindodin - Zolfaghar 1 N18
City
Qom
Province
Ghoum
Postal code
3713197773
Phone
+98 25 3270 7520
Email
kosar1171@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Derakhshan
Position
Master Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qom - Zeinodin - Zolfaghar 1 - p 18
City
Qom
Province
Ghoum
Postal code
3713197773
Phone
+98 25 3270 7520
Fax
Email
kosar1171@gmail.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
Yes - There is 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
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document
There is no more information
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