To determine the effect of foot reflexology massage on fatigue and pain of children with leukemia who undergo chemotherapy
Design
The clinical trial included three groups:Intervention1: (Foot Reflexology Massage) ،intervention2: (touch therapy) and Control group, Factorial،unblinded, Without randomization،Sample size:99child
Settings and conduct
The researcher obtains the necessary documentation.the oncology departments،Ali Asghar and Children's Medical Center Hospitals، children aged 4 to 14 years، with leukemia، undergoing chemotherapy.
Intervention 1 (foot reflexology massage ،Within 5 days،Between 17 and 19 hours، For both feet 30 minute)
Intervention group two (Touch Therapy،Within 5 days،Between 17 and 19 hours، For both feet 30 minute)
And the control group (receiving only routine care).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
There are no scars or physical problems in the feet and massage area.
Any child who does not have a physical problems. (For example: Verbal, Visual, Mental, Hearing).
Reflexology massage or similar treatments were not received during the study.
Exclusion criteria:
The child does not feel comfortable touching his or her feet and doing reflexive massage.
The child is anxious by touching his or her feet and doing a reflexive massage.
The child's illness is severe
The doctor will not allow the intervention
Intervention groups
Group 1: Foot Reflexology for 5 days
Group 2: Touch Therapy for 5 days
Group 3: control Group(receiving only routine care)
Main outcome variables
Pain; fatigue; sleep; anxiety; vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N7
Registration date:2019-09-24, 1398/07/02
Registration timing:retrospective
Last update:2019-09-24, 1398/07/02
Update count:0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-05-15, 1398/02/25
Trial completion date
2019-05-15, 1398/02/25
Scientific title
The effects of foot reflexology massage on fatigue and pain in children with leukemia under Chemotherapy.
Public title
The effects of foot reflexology massage on fatigue and pain in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
There are no scars or physical problems in the feet and massage area
Any child who does not have a physical problems. (For example: Verbal, Visual, Mental, Hearing)
Reflexology massage or similar treatments were not received during the study.
Exclusion criteria:
The child does not feel comfortable touching his or her feet and doing reflexive massage.
The child is anxious by touching his or her feet and doing a reflexive massage.
The child's illness is severe
The doctor will not allow the intervention
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Actual sample size reached:
99
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences؛ next to Milad Tower؛ Hemat Highway؛ Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.525
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
D77
ICD-10 code description
Other disorders of blood and blood-forming organs in diseases classified elsewhere
2
Description of health condition studied
Reflexology
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Fatigue
ICD-10 code
ICD-10 code description
4
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fatigue severity
Timepoint
Before intervention, day 3 and day 5 during five-day reflexology massage
Method of measurement
Child Fatigue Scale
2
Description
Severity of pain
Timepoint
Before intervention, day 3 and day 5 during five-day reflexology massage
Method of measurement
visual analogue scale pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: Then oncology departments at hospitals, "Ali Asghar and Children's Medical Center Hospitals " among children 4 to 14 years old with leukemia who are undergoing chemotherapy. Methods: (Reflexology foot massage, for 5day, between 17and 19hours, 30minutes for both feet).
Category
Rehabilitation
2
Description
Intervention group two:Then oncology departments at hospitals, "Ali Asghar and Children's Medical Center Hospitals " among children 4 to 14 years old with leukemia who are undergoing chemotherapy. Methods: (Touch therapy, for 5day, between 17and 19hours, 30minutes for both feet)
Category
Rehabilitation
3
Description
Control group:Then oncology departments at hospitals, "Ali Asghar and Children's Medical Center Hospitals " among children 4 to 14 years old with leukemia who are undergoing chemotherapy. Methods:control group (receiving only routine care).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Soroor Sohrabi
Street address
Ali Asghar hospital؛ Shahid Dasgerdi street؛ Tehran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
soroor.soh@gmail.com
2
Recruitment center
Name of recruitment center
Childrens medical center Hospital
Full name of responsible person
Tahereh khan Mohamadzadeh
Street address
Childrens Medical Center؛ Number 62؛ Keshavarz blvd؛ Dr. Qarib street, Tehran
City
Tehran
Province
Tehran
Postal code
1511419733
Phone
+98 21 6147 2917
Email
cmc.tums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seid Kazam Malakuti
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
PR@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After Data coding in order to keep the confidentiality of the participants in the research
When the data will become available and for how long
The end of sampling till six months after article publishing.
To whom data/document is available
Ethical, Reviewer and Editorial committees, Researchers.
Under which criteria data/document could be used
Systematic review and meta-analysis or secondary analysis citation.
From where data/document is obtainable
Dr. Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to academic email, we will send our data files up to one week.