The effect of energy saving-related education on fatigue hospitalization children with cancer
Design
Sixty Children With Cancer in Hematology Ward Will be selected by available Sampling and Will be Randomly Assigned to the Experimental and Control Groups
Settings and conduct
In the intervention group, the parents will be completed fatigue questionnaire at first, Then we will start educating the children, and the parents will complete the questionnaire one week after the intervention. Training will be in 4 sessions . In the first day we will first explain the cancer and its complications and explain fatigue. On the third day we will teach you how to save energy and exercise and regular activities. On the fourth day we will provide adequate sleep training and on the seven day we will learn how to deal with stress
Participants/Inclusion and exclusion criteria
inclusion؛ Age Between 6 and 16 years; Exclusion; Patient and Parent Dissatisfaction
Intervention groups
Intervention group: Energy saving education
Control group: no specific intervention
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N5
Registration date:2019-12-27, 1398/10/06
Registration timing:retrospective
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Energy Saving-Related Education on Fatigue Children With Cancer
Public title
The Effect of Energy Saving-Related Education on Fatigue Children With Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age Between 6_16 Years
The definitive diagnosis of cancer and having chemotherapy at least once
Exclusion criteria:
Patient and Parent Dissatisfaction
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants based on random allocation blocks, placed in ten blocks of six, three samples in group A (intervention) and three samples in control group
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.UMSHA.REC.1398.252
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Fatigue
Timepoint
Before The Intervention and 7 Days After The Intervention
Method of measurement
Fatigue Questionnaire for Children With Cancer
Secondary outcomes
empty
Intervention groups
1
Description
In The Intervention Group, The Parents Will be Completed Fatigue Questionnaire at First, Then We Will Start Educate The Children, and The parents Will Complete The Questionnaire One Week After The Intervention. Training Will be in 4 Sessions . In The First Day We Will First Explain The Cancer and its Complications and Explain Fatigue. On The Third Day We Will Teach You How to Save Energy and Exercise and Regular Activities. On the Fourth Day We Will Provide Adequate Sleep Training and on the Seven Day We Will Learn How to Deal With Stress.
Category
N/A
2
Description
Control group: They will not receive any intervention; Only Fatigue questionnaire twice within a week will be completed by parents.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, Pediatric Hematology Ward
Full name of responsible person
Marziyeh Moeinifard
Street address
Hamadan Besat Hospital
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3525 0182
Email
nrs.1994m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
ICT@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arash Khalili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
a.khalili@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fatemeh Cheraghi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Fax
Email
f.cheraghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arash Khalili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmide Street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
a.khalili@umsha.ac.ir
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
No More Information
Study Protocol
No - There is not 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