Objectives:The aim of this study is the determination The effect of foot reflexology on intensity fatigue and chronic musculoskeletal pain in hemodialysis patients.
Design of study: A randomized single blind without placebo controlled study in the Ali ebn abitaleb(s) hospital of Zahedan University of Medical Sciences.
participants: All patients undergoing hemodialysis referring to the Ali ebn abitaleb(s) hospital in zahedan in 2017.
Inclusion criteria: At least 18 years of age; A history of at least 6 months of dialysis; Be on the weekly dialysis list
A sample of 90 patients ( 45 intervention and 45 control) will be selected. In both groups، Fatigue Severity Scale(FSS) and Visual Analogue Scale(VAS) Questionnaires (pretest) will be filled half an hour after starting dialysis. In intervention group، for half an hour, both feet of patients (each legs 15 min) will be massaged in reflex points on the soles of the feet. At the end of dialysis questionnaires will be filled in both groups (posttest). In intervention group massage will be done for three consecutive sessions of dialysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100736612N1
Registration date:2017-11-20, 1396/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Simin Sharifi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+54 33442481
Email address
sharifi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- Chancellor in Research Affairs Zahedan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on intensity fatigue and chronic musculoskeletal pain in hemodialysis patients
Public title
The effect of foot reflexology on intensity fatigue and chronic musculoskeletal pain in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:At least 18 years of age ; A history of at least 6 months of dialysis ; Be on the weekly dialysis list
Exclusion: Unwillingness to continue to participate in the scheme ; Injection blood products and Drugs such as Calcitrile and Venofer in intervention
Age
From 18 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
Ethic committee Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Khalije Fars Boulevard,Dr Hesabi Square
City
Zahedan
Postal code
98167-43463
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1396.155
Health conditions studied
1
Description of health condition studied
fatigue
ICD-10 code
F48.0
ICD-10 code description
Neurasthenia
2
Description of health condition studied
chronic musculoskeletal pain
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
fatigue
Timepoint
Before and immediately after the intervention
Method of measurement
Fatigue Severity Scale
2
Description
Chronic musculoskeletal pain
Timepoint
Before and immediately after the intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group، for half an hour, both feet of patients (each of the legs 15 min) reflex points on the soles of the feet massage will be given.(Massage on the foot of the foot will apply at the point that is related to the kidneys)
Category
Other
2
Description
in control group no intervention required
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abitaleb(s) hospital
Full name of responsible person
Abouzar shamsoddini
Street address
Zahedan University of Medical Sciences
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor in Research Affairs Zahedan University of Medical Sciences
Full name of responsible person
Dr noormuhammad bakhshani
Street address
Zahedan University of Medical Sciences, Khalije Fars Boulevard , Dr Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor in Research Affairs Zahedan 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
Zahedan Faculty of Nursing and Midwifery
Full name of responsible person
Abouzar Shamsoddini
Position
master student of nursing
Other areas of specialty/work
Street address
Behdasht blvd - Zahedan Faculty of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
Email
mahdishamsoddini12@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan Faculty of Nursing and Midwifery
Full name of responsible person
Simin Sharifi
Position
PHD
Other areas of specialty/work
Street address
Behdasht blvd Zahedan Faculty of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
Email
siminsharifi1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan Faculty of Nursing and Midwifery
Full name of responsible person
Abouzar Shamsoddini
Position
Master Students of critical care Nursing
Other areas of specialty/work
Street address
Behdasht blvd Zahedan Faculty of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
Email
mahdishamsoddini12@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)