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Comparison of foot and hand Reflexology on fatigue in patients undergoing hemodialysis

Protocol summary

Summary
Fatigue is the most common symptom reported by patients undergoing hemodialysis. This study aimed to investigate the effect of foot reflexology massage and hand fatigue patients on dialysis; and if approved foot and hand reflexology massage effect and compare the two methods in reducing fatigue in patients undergoing hemodialysis and if the results are equal foot reflexology massage hand, because of its convenience for patients and nurses, and also teach patients to use this method, you can place the palms reflexology massage foot reflexology massage can be used to reduce or eliminate fatigue in these patients. This study is a randomized clinical trial in men and women in the study population hemodialysis Hashemi Nejad Hospital Tehran, Iran. Random assignment in three foot reflexology massage, reflexology massage and hand control is performed. Reflexology massage for test procedures and duration of the program is described. In the intervention group for the 3-point massage, reflexology foot and hand reflexology, including the pituitary gland, solar plexus and the kidney is performed. On each of these points reflexology are a total of 3 minutes on both feet and both hands for about 20 minutes takes. Foot and hand reflexology massage 2 times a week, each session lasting 20 minutes and 5 weeks is done by a trained researcher. After the end of the third week and the fifth week fatigue set the scale to be completed by both groups. After completing this scale, according to the scores obtained, tired in the classification of patients: fatigue, mild (39-10), moderate fatigue (54-40) and fatigue (70-55) placed.

General information

Acronym
Reflexology
IRCT registration information
IRCT registration number: IRCT201312222226N12
Registration date: 2014-03-03, 1392/12/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing and Midwifery Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2014-02-19, 1392/11/30
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of foot and hand Reflexology on fatigue in patients undergoing hemodialysis
Public title
Comparison of foot and hand Reflexology on fatigue in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age at least 18 years old and at least 6 months of dialysis; willingness to participate in this study; being on the list and do the weekly dialysis three times a week, each time for 3 or 4 hours of hemodialysis; having full awareness, listening and speaking ability acceptable to answer questions; to develop a degree of fatigue on the Fatigue Severity Scale; lack of fever and bleeding and thrombosis, numbness or paralysis of the limbs. Exclusion criteria: in case of the any of these conditions during the study, the unit of study will be excluded: patients died during the study; transplantation during the study; any condition in which the patient's foot or hand reflexology massage; did not cooperate with the investigator during study and hemodynamic instability during hemodialysis.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing ethics committee of Tehran University of Medical Sciences
Street address
squar toohid-nursing&midwifery facultyTehran University of Medical Sciences-tehran-iran
City
Tehran
Postal code
1419733171
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
92/د/130/2416

Health conditions studied

1

Description of health condition studied
Fatigue in Hemodialysis Patients
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
Fatigue reduces the hand and foot reflexology massage
Timepoint
Before the intervention, the end of the third week, the fifth week
Method of measurement
Fatigue Questionnaire (Fss)

Secondary outcomes

empty

Intervention groups

1

Description
Foot reflexology massage 2 times a week, each session lasting 20 minutes and 5 weeks is done by a trained researcher.In the Beginning and After the end of the third week and the fifth week fatigue set the scale to be completed by intervention group1.
Category
Other

2

Description
The control group received no intervention. In the Beginning and After the end of the third week and the fifth week fatigue set the scale to be completed by control group .
Category
Other

3

Description
Hand reflexology massage 2 times a week, each session lasting 20 minutes and 5 weeks is done by a trained researcher.In the Beginning and After the end of the third week and the fifth week fatigue set the scale to be completed by intervention group2.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Hashemi Nejad hospital, Iran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpour
Street address
valinejad st.-squar vanak- valiasr street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yonesian
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Keshavarse bulvar, Ghods street
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Tehran University of Medical Sciences
Full name of responsible person
Sayyed Abdolmotallab Hassani
Position
MSc nursing
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery,Tehran University of Medical Sciences, East Nosrat st., Toohid square
City
Tehran
Postal code
Phone
+98 12 1263 2201
Fax
Email
a.hassani1368@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpoor
Position
MSc
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, East Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sayyed Abdolmottalab Hassani
Position
MSc candidate
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery,Tehran University of Medical Sciences, East Nosrat st., Toohid square
City
Tehran
Postal code
Phone
+98 12 1263 2201
Fax
Email
a.hassani1368@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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