comparison the effect of acupressure in the Pericardium 6 ( pc6) &ُ Shenmen ( HT7) points & foot reflexology on sleep habits disorder children with leukemia under chemotherapy
The aim of this study was to comparison the effect acupressure and reflexology on sleep habits disorder in children with leukemia under chemotherapy
Design
Design of study: A randomized , with parallel group, not blinded, with controlled group; Society studied is 60 children with leukemia under chemotherapy Hospitalization in the Doctor Sheikh hospital of Mashhad.
Settings and conduct
The study is done at Doctor Sheikh Hospital in Mashhad, Iran. Sampling were available and assigned to the study groups using stratified random time blocks method
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 6-12 years with leukemia, no previous at treatment sessions of complementary medicine such as reflexology, relaxation & massage methods for last 6 month, not being foot palm inflammation, infection lack of ulcer and fracture at the pressure points, none congenital disorders having sleep disorder higher than 41 on The Children's Sleep Habits Questionnaire (CSHQ).
Exclusion criteria: Patient’s unwillingness to continue the collaboration in this study
Intervention groups
Three group. receiving accupressure receiving reflexology and control group
In the intervention group accuprssure massage will be conducted on the pc6 , HT7 points for 3 day , day by day within 1 week
In the intervention group reflexology massage will be conducted on the Foot thumb for 3 day , every other day within 1 week
The control group did not receive any intervention other
Main outcome variables
sleep habits disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171115037481N2
Registration date:2018-06-23, 1397/04/02
Registration timing:retrospective
Last update:2018-06-23, 1397/04/02
Update count:0
Registration date
2018-06-23, 1397/04/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3452 4555
Email address
rezaeiz951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-23, 1396/10/02
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
2017-12-23, 1396/10/02
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
comparison the effect of acupressure in the Pericardium 6 ( pc6) &ُ Shenmen ( HT7) points & foot reflexology on sleep habits disorder children with leukemia under chemotherapy
Public title
comparison the effect of acupressure & reflexology on sleep habits disorder leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 6-12 years with leukemia
no previous at treatment sessions of complementary medicine such as reflexology, relaxation & massage methods for last 6 month
not being foot palm inflammation or infection
lack of ulcer and fracture at the pressure points
do not use hypnotics
experience at least one course of childhood treatment with chemotherapy
permitted by doctor
none congenital disorders
having sleep disorder higher than 41 on The Children's Sleep Habits Questionnaire (CSHQ)
Exclusion criteria:
Patient’s unwillingness to continue the collaboration in this study
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The research units according to the sequences that generated by SPSS software before the start of the study were randomly divided into Reflexology and Accuprressure intervention and control groups
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
Ethic committee of Mashhad university of medical siences
Street address
Ghoreishi building.daneshgah street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.MUMS.REC.1396.319
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C95
ICD-10 code description
Leukaemia of unspecified cell type
Primary outcomes
1
Description
sleep habits disorder
Timepoint
At beginning the study and one week later
Method of measurement
Questionarre children's sleep habits CSHQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: accupressure . In the intervention group accuprssure massage will be conducted on the pc6 , HT7 points for 3 day, every other day, within 1 week.
Category
Treatment - Other
2
Description
Intervention group: reflexology. In the intervention group reflexology massage will be conducted on the Foot thumb for 3 day, every other day, within 1 week
Category
Treatment - Other
3
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Doctor Sheikh hospital
Full name of responsible person
Dr Zahra Badee
Street address
Doctor Sheikh Hospital, Tohid Square, Motahari Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
917351358
Phone
+98 51 3726 9021
Email
Shaikh.hospital@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi building. Daneshgah street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Phone
+98 51 3845 1530
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Rezaei
Position
Nursing Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
school of Nursing & Midwifey, Ibn sina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Rezaeiz951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Monir Ramezani
Position
Ph.D Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of Nursing & Midwifey, Ibn sina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Ramezanimn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Rezaei
Position
Nursing Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
school of Nursing & Midwifey, Ibn sina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Rezaeiz951@mums.ac.ir
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
Undecided - It is not yet known if there will be 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